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. 2023 Sep 1;102(35):e34841. doi: 10.1097/MD.0000000000034841

Repetitive transcranial magnetic stimulation in the treatment of middle-aged and elderly major depressive disorder: A randomized controlled trial

Xiaofang Wang a, Xiubo Fan a, Lihui Zhang a, Xin Liu a, Zhi Ji a,*
PMCID: PMC10476736  PMID: 37657019

Abstract

Background:

Studies have reported the use of repetitive transcranial magnetic stimulation (rTMS) in patients with major depressive disorder (MDD). However, most studies focus on antidepressant effect of rTMS, but few on cognitive aspects. The present study aimed to explore the effect of rTMS on BDNF levels and cognitive function in the treatment of middle-aged and elderly MDD.

Methods:

This was a randomized controlled trial. A total of 120 elderly patients with MDD treated in The Second Affiliated Hospital of Xi’an Medical University from January 2021 to January 2023 were selected as research subjects. The patients were randomly divided into control group (n = 60, patients received simple oral treatment with escitalopram and sham rTMS) and study group (n = 60, patients received oral treatment with escitalopram combined with rTMS) according to the random number table method. We compared the clinical efficacy, serum BDNF levels, and cognitive function between the 2 groups.

Results:

After treatment, the HAMD-17 score in the study group was lower than that in the control group [13.00 (12.00–16.00) vs 17.00 (15.00–19.00), P < .05], and the RBANS score was higher than that in the control group [166.00 (161.25–171.75) vs 133.00 (130.00–136.75), P < .05]. The total effective rate of the research group was 95.0%, which was higher than the 82.0% of the control group (P < .05). The serum BDNF levels [36.00 (33.00–38.00) vs 30.00 (28.00–32.00), P < .05] and MoCA scores [24.00 (22.00–26.75) vs 23.00 (21.00–25.00), P < .05] of the study group were higher than those of the control group. There were no significant adverse reactions during the treatment of both groups.

Conclusions:

Compared with oral escitalopram alone, repeated transcranial magnetic stimulation in the treatment of middle-aged and elderly patients with major depressive disorder can further improve the efficacy, and can more effectively improve the BDNF level and cognitive function, with ideal safety.

Keywords: cognitive function, major depressive disorder, repetitive transcranial magnetic stimulation, serum brain-derived neurotrophin

1. Introduction

Depression is one of the common clinical mental diseases, with an annual incidence of 5% to 15%.[1] Its symptoms include emotion, motivation, cognition and many other aspects, specifically manifested as depression, lack of pleasure, memory decline, etc., which seriously affects the quality of life of patients.[1,2] Moreover, major depressive disorder (MDD) patients are often accompanied by suicidal ideation or behavior.[1] Relevant studies have shown that the suicide mortality rate of depression has been continuously increasing in recent years, reaching 10% to 15%. This not only causes significant harm to families, but also affects social stability and harmony.[2] At present, MDD is mainly treated with drugs in clinical practice. Although there are many antidepressants, not all patients respond to antidepressants, so further exploration of effective treatment plans is needed.[2,3] Repetitive transcranial magnetic stimulation (rTMS) is a commonly used physical therapy technique, where an electric current passes through a magnetic coil to generate a pulsed magnetic field that affects the brain, affecting neural electrical activity in the brain and altering cortical cell excitability.[3] In recent years, it has gradually been widely used in the treatment of neurological and psychiatric diseases.[3,4]

Studies have shown that rTMS not only has a significant impact on symptoms of depression and anxiety in treatment resistant depression (TRD), but also in non-TRD patients with MDD.[5,6] A recent study found that treatment regimens combining high pulse doses and multiple daily treatments of rTMS showed improved efficacy for MDD.[7] rTMS has also been proved to be an effective and safe a treatment for elderly patients with MDD.[8]

Cognitive impairment is one of the common functional impairments of depression, and it is a long-term persistent symptom that runs through the whole disease cycle. Though a large number of studies have investigated the effects of rTMS in patients with MDD, few studies have investigated the BDNF level of these patients receiving rTMS. Clinical studies have shown that serum BDNF is closely related to cognitive impairment, and the abnormal expression of BDNF in depression is one of the main reasons for cognitive impairment.[9,10] Based on this, 114 elderly patients with MDD who received rTMS from January 2020 to January 2022 were enrolled as research subjects, and BDNF and cognitive function were used as the main observation indicators to further analyze the application effect of rTMS in MDD treatment.

2. Materials and methods

2.1. Research subjects

This was a randomized controlled trial. A total of 120 middle-aged and elderly patients with MDD who were treated in The Second Affiliated Hospital of Xi’an Medical University from January 2021 to January 2023 were selected as the research subjects. The patients were randomly divided into control group (n = 60, patients received simple oral treatment with escitalopram and sham rTMS) and study group (n = 60, patients received oral treatment with escitalopram combined with rTMS) according to the random number table method. The control group consisted of 19 males and 41 females; Age range from 48 to 79 years old, with an average of 65.73 ± 7.25 years old; The course of the disease is 1 to 8 years, with an average of 4.53 ± 1.56 years. The research group includes 25 males and 35 females; Age range from 46 to 79 years old, with an average of 66.55 ± 7.95 years old; The course of the disease is 1 to 8 years, with an average of 4.72 ± 1.38 years. There was no statistically significant difference in general data between the 2 groups of patients (P > .05) (Table 1; Fig. 1).

Table 1.

Comparison of general data between the 2 groups.

Group n Gender (Male/female) Age (yr) Course of disease (yr) HAMD-17 (scores) Education level (n) Mean dose of Escitalopram tablets (mg/d)
High school below High school and above
Control group 60 19/41 65.73 ± 7.25 4.53 ± 1.56 29.47 ± 2.46 45 15 11.25 (10, 15)
Study group 60 25/35 66.55 ± 7.95 4.72 ± 1.38 29.73 ± 2.39 50 10 11.25 (10, 15)
χ2/t/Z – 1.292 −0.588 −0.683 −0.602 1.263 −0.458
P – .256 .558 .496 .548 .261 .647
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HAMD-17 = Hamilton Depression Rating Scale 17.

Figure 1.

Figure 1.

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Patient inclusion flowchart. A total of 120 middle-aged and elderly patients with MDD were included, with 60 cases in each group. MDD = major depressive disorder.

All procedures conducted in research involving human participants comply with the ethical standards of institutions and/or national research committees, as well as the Helsinki Declaration (revised in 2013). Obtain written informed consent from the patient or legal guardian. We obtained written informed consent from the patient or legal guardian and the Medical Ethics Committee of The Second Affiliated Hospital of Xi’an Medical University approved this study (Number: X2Y202305; Date: April 23th, 2023).

1.2.1. Inclusion criteria.

  • -

    Meets MDD diagnostic criteria;

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    Age ≥ 45 years old and < 80 years old;

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    Those who did not receive any antidepressants 4 weeks before enrollment;

2.2.1. Exclusion criteria.

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    Patients with other mental or brain disorders such as schizophrenia, epilepsy, dementia, and mania;

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    Organic diseases leading to depression;

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    Other serious underlying diseases, organ dysfunction, and malignant tumor comorbidities;

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    History of brain surgery and injury;

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    Severe suicidal tendencies;

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    Contraindications to medication and treatment methods in this study.

2.2. Methods

The control group was given oral treatment with escitalopram. The initial dose of escitalopram tablets (Sichuan Kelun Pharmaceutical Co., Ltd., Chengdu, Sichuan, China, H20080788, specification: 10mg * 10 s/box) is 5 to 10 mg/d. Subsequently, based on the patient’s condition, the dose is gradually increased to 20 mg/d for 8 weeks.

The research group was treated with escitalopram tablets and rTMS was performed on the basis of treatment. For the rTMS treatment, a MagPro magnetic stimulator (Brand: Medtronic) was used. All metal objects of the patients were removed before treatment. The patients was placed in the supine position, the stimulation area was selected on the left dorsolateral frontal cortex, and an 8-shaped coil was selected. At a stimulation frequency of 10 Hz, the motor threshold was gradually increased from 80% to 110%. The stimulation lasted 5 seconds/time, with an interval of 25 seconds, once a day, 20 minutes each time. The patients were treated continuously for 5 times from Monday to Friday, and have a rest on weekends. Four weeks is one course of treatment, and all patients received 2 courses of treatment.

2.3. Observation indicators and effectiveness evaluation:

Efficacy evaluation, BDNF level detection, and cognitive function evaluation. Efficacy evaluation method: Hamilton Depression Rating Scale 17 (HAMD-17), including anxiety/somatization (6 items), block (4 items), cognitive impairment (3 items), sleep disorders (3 items), and 5 factors of weight change. A total score of < 7 indicates asymptomatic symptoms, 8 to 16 points indicates mild depression, 17 to 24 points indicates moderate depression, and > 24 points indicates severe depression;[10] After treatment, if the total score of HAMD-17 is ≤ 7 points, it is considered cured. If the reduction rate of HAMD-17 after treatment is ≥ 50%, it is considered effective. If the reduction rate of HAMD-17 after treatment is less than 50%, it is considered ineffective. The total effective rate = (number of cured cases + number of significantly effective cases)/total number of cases × 100%.[11] The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a brief battery consisting of 12 measurement items and 5 factors. The higher the score, the better the psychological state.[12] BDNF level detection method: collect fasting venous blood samples, take serum after centrifugation, and detect by ELISA. The kit was purchased from RayBio Company in the United States. Cognitive function evaluation method: The Montreal Cognitive Assessment (MoCA) consists of 12 questions, with a total score of 0 to 30 points. A score below 26 indicates cognitive impairment, and the lower the score, the more severe the cognitive impairment.[13]

2.4. Statistical analysis

Categorical variables were compared via Fisher’s exact test or Chi-squared tests. Continuous variables are means ± SD (standard deviation) and were compared via Student’s t tests or Mann–Whitney’s U tests. P < .05 was the significance threshold. SPSS v26.0 (SPSS Inc., Chicago, IL) was used for all statistical testing.

3. Results

3.1. Comparison of HAMD and RBANS scores between 2 groups before and after treatment

Before treatment, there was no significant difference in HAMD-17 and RBANS scores between the 2 groups (P > .05); After treatment, the HAMD scores of both groups of patients decreased compared to before treatment, and the study group had a lower score [13.00 (12.00–16.00) vs 17.00 (15.00–19.00), P < .05]. The RBANS scores were all higher than before treatment, and the study group was higher [166.00 (161.25–171.75) vs 133.00 (130.00–136.75), P < .05] (Fig. 2).

Figure 2.

Figure 2.

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Comparison of HAMD and RBANS scores between the 2 groups before and after treatment. After treatment, the HAMD score of the study group was significantly lower than the control group, while the RBANS was significantly higher in the study group. HAMD-17 = Hamilton Depression Rating Scale 17, RBANS = Repeatable Battery for the Assessment of Neuropsychological Status.

3.2. Comparison of clinical efficacy between 2 groups of patients

The total effective rate of the study group was 95.0%, which was higher than the 80.0% of the control group (P < .05) (Table 2).

Table 2.

Comparison of total effective rate between the 2 groups [n (%)].

Group n Curative effect Total effective rate
Cure Apparent effect Effective
Control group 60 7 (11.7) 33 (55.0) 8 (13.3) 48 (80.0)
Study group 60 23 (38.3) 31 (51.7) 3 (5.0) 57 (95.0)
 χ2 – – – – 16.269
 P – – – – .001
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3.3. Comparison of BDNF levels and cognitive function between 2 groups of patients before and after treatment

There was no significant difference in BDNF levels and cognitive function between the 2 groups before treatment (P > .05). After treatment, the BDNF levels and MoCA scores of both groups increased compared to before treatment, and the study group had higher levels [BDNF 36.00 (33.00–38.00) vs 30.00 (28.00–32.00), P < .05; MOCA 24.00 (22.00–26.75) vs 23.00 (21.00–25.00), P < .05] (Fig. 3).

Figure 3.

Figure 3.

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Comparison of BDNF level and MoCA score before and after treatment between the 2 groups. BDNF levels and MoCA scores were higher in both groups after treatment than before treatment, and the levels were higher in the study group. MoCA = Montreal Cognitive Assessment.

3.4. Adverse reactions during treatment in both groups

During the treatment period, neither group of patients experienced any significant adverse reactions and successfully completed 2 courses of treatment.

4. Discussion

MDD is often associated with cognitive problems. Different from most previous studies on the antidepressant effect of rTMS on MDD, the present study focused on serum BDNF level and cognitive function, and found that compared to the simple oral treatment of escitalopram with sham rTMS, the clinical effect of escitalopram combined with rTMS in the treatment of MDD is more significant, and it can also improve the serum BDNF levels and cognitive function of patients. The findings may provide more evidence to support the clinical application of rTMS in treating MDD.

Depression is a common mental and psychological disorder, and the current pathogenesis has not been fully elucidated. However, clinical research suggests that it is related to various physiological, psychological, and social factors, such as low mood, loss of interest, and lack of pleasure.[14] At present, the treatment of depression in clinical practice mainly relies on medication, physical therapy, psychological therapy, etc. In this study, rTMS was administered to MDD patients on the basis of oral escitalopram tablets. The results showed a total effective rate of 95.0%, similar to the study by Wilke et al,[15] indicating that rTMS can further improve the efficacy and alleviate symptoms in the treatment of MDD patients. RTMS is a type of physical therapy that was first proposed in 1985 and found to stimulate both the brain and nerves.[16] In recent years, it has been widely used in the treatment of mental disorders such as depression and schizophrenia. Functional areas such as the prefrontal cortex and subcortical cingulate gyrus are closely related to human emotional management and are common functional disorders in patients with depression.[15,16] Transcranial magnetic stimulation therapy can stimulate this area, activate specific neural circuit activities, and achieve the effect of regulating the emotional state of the brain and improving the emotional status of patients.[16,17] In addition, a large number of animal model studies in recent years have shown that rTMS is similar to antidepressants in the treatment of depression, and can promote the formation of hippocampal neurons.[18] For example, Spitz et al[17] study on the implementation of rTMS in the model of depression mice found that the level of BrdU positive cells in the dentate gyrus of the hippocampus increased significantly in mice, further indicating that this treatment can have a good inhibitory effect on depression. Moreover, a large number of clinical studies believe that depression is essentially a type of brain functional mediation disorder, with cognitive, behavioral and other impairments, specifically manifested as decreased attention and impaired executive function. Therefore, when treating depression patients, attention should be paid to improving cognitive function.[18,19]

Cognitive function is mainly regulated by the neural circuit composed of basal ganglia and cerebral cortex in the nervous system, and the state of the nervous system will also cause cognitive function damage.[19] At the initial stage of depression, cognitive impairment is mainly affected by specific biological changes in brain regions, and a large number of anatomical studies have confirmed that depression patients have structural changes in hippocampus and amygdala regions.[20] Other studies have shown that a decrease in neurons and glial cells in patients with depression can lead to a decrease in neurological function and lead to cognitive impairment.[21] BDNF is a kind of neurotrophin, which is produced by neurons and glial cells, and can protect nerve cells and promote the development of neurons. A large number of clinical studies have shown that the serum BDNF level in patients with depression decreases, and after tibial treatment, the blood BDNF level shows a significant upward trend.[21,22] RTMS can improve brain metabolism and blood flow, increase cerebral cortex blood flow perfusion, promote nerve cell growth, and regulate the level of computer neurotransmitters, thus affecting cognitive function.[22] The present study found an increased BDNF levels in study group after treatment, which is consistent with previous studies.[23,24] The study by Vogel and Soti[25] suggests that after receiving rTMS treatment, patients with depression experience an increase in the release of dopamine from the striatum, an increase in serum BDNF levels, and an improvement in cognitive function. It should be pointed out that the improvement mechanism of rTMS on cognitive impairment is currently not fully elucidated, and further research is needed in this regard.[22,25] In addition, a large number of clinical studies have shown that rTMS treatment does not lead to physiological activity disorders such as heart rate and blood pressure, and there are generally no obvious complications during the treatment process. A few reports have suggested that the main complaint of headache is mostly considered tension headache, which can be relieved after rest or oral painkillers.[26,27] In this study, no significant adverse reactions were observed during the treatment of patients, further indicating the ideal safety of rTMS in the treatment of middle-aged and elderly MDD.

4.1. Limitations

The study has some limitations. First of all, only 120 patients were included, and the treatment period was only 8 weeks. Without long-term follow-up observation, the long-term safety cannot be determined. Second, the included observation indicators were also limited, and the conclusion was subjective and one-sided. In the clinical practice, when using rTMS to treat MDD, it is necessary to study other parameters that can evaluate the health level of elderly patients, which will help provide corresponding references for the in-depth application of rTMS. Third, the improvement of the cognitive function may be caused by the state of MDD or the relief of affective symptoms of the patients. Whether rTMS has a direct effect on cognitive impairment is not yet clear and needs to be verified by more studies.

5. Conclusion

rTMS is an emerging noninvasive neuromodulation for the treatment of depression in recent years. A growing body of research supports its use in clinical practice as a monotherapy or in combination with drug therapies. The safety profile and good tolerability of rTMS enables it to overcome the dilemma of the elderly population with multiple comorbidities and difficulty in choosing antidepressant drugs. Our study showed that compared with oral administration of escitalopram alone, the use of rTMS in the treatment of MDD can further improve the efficacy, improve serum BDNF levels and cognitive function in patients more effectively, and have no significant adverse reactions. However, due to the small sample size, limited observation indicators, short-term follow-up included this study, multi-center large randomized trials with long-term follow-up are required to further validate our findings.

Author contributions

Conceptualization: Xiaofang Wang.

Data curation: Xiaofang Wang, Xiubo Fan, Xin Liu.

Formal analysis: Lihui Zhang.

Investigation: Xin Liu.

Writing – review & editing: Xiaofang Wang, Zhi Ji.

Abbreviations:

HAMD-17
Hamilton Depression Rating Scale 17
MDD
major depressive disorder
MoCA
Montreal Cognitive Assessment
RBANS
Repeatable Battery for the Assessment of Neuropsychological Status
rTMS
repetitive transcranial magnetic stimulation

Our study was approved by the Ethics Review Board of Lianyungang Traditional Chinese Medicine Hospital.

The authors have no funding and conflicts of interest to disclose.

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

How to cite this article: Wang X, Fan X, Zhang L, Liu X, Ji Z. Repetitive transcranial magnetic stimulation in the treatment of middle-aged and elderly major depressive disorder: A randomized controlled trial. Medicine 2023;102:35(e34841).

Contributor Information

Xiaofang Wang, Email: yiyi190348@163.com.

Xiubo Fan, Email: Lxts007@163.com.

Lihui Zhang, Email: 1062935708@qq.com.

Xin Liu, Email: Ziliuhe1224@163.com.

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