Table 1.
Author, year | Study type, disorder (primary) | Number of participants, age, gender | Conditions Electrode positioning, intensity, duration, number of stimulations |
Operator, mode of supervision | Adverse effects, feasibility | Outcome parameters, results | Strengths (S) and weakness (W) | Quality measures during stimulation series A = adherence control Q = quality of stimulation S = safety assessment T = technical monitoring V = regular visits |
---|---|---|---|---|---|---|---|---|
Alonzo et al. [26] | Open label pilot trial, major depressive episode of a unipolar or bipolar depression, at least 4 weeks | N = 34, group 1: N = 15, 6 female, 48.64 ± 11.56 years, group 2: N = 20, 7 female, 46.10 ± 13.55 years | Single condition, active: anode F3, cathode F8, 2 mA, 30 min, 20 or 28 sessions in 4 weeks and taper phase of 4 sessions in 4 weeks | Standardized training and checklist in clinic (1 session), Self-administered by patients, remotely observed by research staff via videolink (as needed) |
No SAEs Most common side effects: tingling, burning, redness Drop-outs: 2: inability to master set-up, missed sessions. 93% of scheduled sessions completed |
Changes from baseline to 1-month follow-up in: MADRS QIDS-SR Q-LES-Q-SF Significant main effect of time in all scales, no effect of session frequency |
S: standardized procedures, regular visits and supervision W: no sham condition |
A = yes Q = yes S = yes T = yes – electrode contact quality V = yes |
Borrione et al. [27] | Case series, open label, combination of home-based tDCS with App based psychological intervention, MDD | N = 5, 4 female, 41.6 ± 9.8 years | Single condition, active + app-based intervention: one-size-fits-all cap, prefrontal, anode left, cathode right, 2 mA, 30 min, 21 sessions in 6 weeks | supervised training, self-administered, remote access to study team in case of any questions or complications |
No SAEs All 5 subjects finished the protocol, no drop-outs |
Changes from baseline to week 6 in: MADRS, Ham-D-17, BDI-II. 4 treatment responders, 3 remission | S: + app-based intervention. W: no control group, only 5 patients, one-size-fits-all cap | A, Q, S, T in supplementary material, not available. V = yes (baseline, week 2, 3, 4, 6) |
Cappon et al. [22] | Open label pilot trial on study companion-administered tDCS at home in older patients with MDD | N = 5 (3), two withdrew in the first week, 0 female; 46–72 years |
Single condition, active, multichannel tDCS montage with Stimweaver algorithm, F3 (anode), FZ, FC5, and FP1 (cathodes), 1,75 mA max. current, 30 min, 37 sessions in 8 weeks |
Study companion-administered after standardized training programme, remote practice sessions, on-demand remote assistance |
No SAEs, most frequently reported tingling, itching, sleepiness, scalp redness. 2 drop-outs: medical conditions unrelated to treatment. Of remained patients only one session was missed |
Changes from baseline to week 4, 8 and 12 (follow-up) in: MADRS, QIDS-SR16, HDRS, BDI-II. MADRS decreased in all 3 completers (average decrease: 59% baseline to 1-month follow-up), same trend for the other scores | S: new training programme, electrode montage multichannel. W: only 3 patients completed, ratings via phone, no control group |
A = yes Q = yes S = yes T = no V = no |
Mota et al. [31] | Randomized, double-blind, sham-controlled clinical trial for home-based tDCS in depression in temporal lobe epilepsy | N = 26 13 active, 12 female 53.38 ± 14.45 years, 12 sham, 10 female 55.76 ± 7.68 years | Active and sham condition, prefrontal: anode left, cathode right, 2 mA, sham: no current, 20 min, 20 sessions in 4 weeks home-based, then 3 sessions in 3 weeks in-clinic | Self-administered after training by a clinician and with instructional video | 7 moderate or severe AEs in active, 3 in sham group: headache, most common side effects were tingling, itching, burning, headache, somnolence, moodswings. Drop-out: 1 (active): pain, burning discomfort. 2 (sham): travel, loss of interest | Changes from baseline to week 2,4, 8 in the BDI-II (primary Outcome), QOLIE-31 and HAM-A score (secondary Outcome), improvement over time but no group difference | S: active and sham, monitoring of technical parameters. W: different groups of medications |
A = yes Q = yes S = yes T = yes V = yes |
Sobral et al. [28] | Case series, open label, combination of home-based tDCS with App based psychological intervention, MDD and/or comorbidities | N = 7, 4 female, 26–51 years old; | Single condition, active + app-based intervention: one-size-fits-all cap, prefrontal, anode left, cathode right, 2 mA, 30 min, 18 or 21 sessions in 6 weeks |
Supervised training, self-administered by patients, clinical progress monitoring in person and remotely using Zoom |
No SAEs, most common AEs: scalp irritation, tingling, itching, and burning sensation. Adherence and acceptability overall high (ACCEPT-tDCS scores), 2 patients missed > 50% tDCS sessions (personal challenges), 1 drop-out (compliance) |
Changes from baseline to week 6 in: MADRS-Self rating and BDI-II, STAI-Trait clinical improvement in MADRS-S in 5 patients and in STAI-Y2 5 patients |
S: combination with app-based intervention W: 2 patients initiated CBT at same time as study, no control group |
A = yes Q = no S = yes T = no V = yes |
Woodham et al. [30] | Open label, single-arm study of home-based tDCS in MDD |
N = 26, 19 female, 40.9 ± 14.2 years |
Single condition, active tDCS, F3 anode, F4 cathode, 2 mA, 30 min, 21 sessions in 6 weeks |
Self-administered, research team member was present in person or by real-time video call at each session |
No SAEs, most common side effects were skin redness, tingling, itching, mild burning sensation, headache. Acceptability rated high, drop-outs: 3 (broken device, physical health, personal reasons), 92,8% completed 6 weeks of treatment |
Changes from baseline to week 6 and after 3 and 6 months follow-up in: HAMD. Response in 22 (20) participants, clinical remission in 21 (18) at week 6 (after 6 months) | S: 26 patients included, long follow-up phase, Acceptability questionnaire. W: no control group |
A = yes Q = no S = yes T = no V = yes |
Le et al. [29] | Case series, retrospectively examined clinical data, MDD | N = 16, no further information, only abstract available | Single condition, active tDCS, different protocols, up to 2 years of treatment, at least 6 weeks | Self-administered at home | No SAEs, 2 patients withdrawn because of blurred vision or exacerbation of tinnitus | 5 patients responded to acute tDCS within 6 weeks, 9 patients who received tDCS for more than 12 weeks maintained improvements over several months | S: long observation period W: no control group, active group very inhomogenious | No further information |
Oh et al. [32] | Randomized, single-blind, sham-controlled clinical trial, parallel group, MDD, home-administered tDCS + Escitalopram 5–20 mg/d |
N = 58, 29 (20) active, 29 (25) sham, 9 drop-outs in active, 4 in sham group, Active: 10 female, 29.7 ± 11.6 years, sham: 10 female 28.5 ± 11.0 years |
Active and sham condition, anode F3, cathode F4, active: 2 mA, sham: no current, 30 min, 30 sessions in 6 weeks | Self-administered at home, instruction once by a research nurse, online manuals |
2 skin burns (forehead) Drop-outs: 13 (9 active: 2 burns, 7 poor treatment compliance; 4 sham: 4 poor treatment compliance) |
Changes from baseline to week 6 in: MADRS, HAM-D, BDI. Improvement in all scales over time, BDI score decrease was significantly different between the active and sham tDCS groups | S: active and sham condition, regular visits. W: single-blinded design |
A = yes Q = no S = yes T = yes (current density) V = yes |
Lee et al. [33] | Randomized, double-blind, sham-controlled clinical trial for home-based tDCS in bipolar depression | N = 64, 47 female, 33.4 ± 12.6 years | Active and sham condition, anode F3, cathode F4, active: 2 mA, sham: no current, 30 min, up to 42 sessions in 6 weeks | Instructions, self-administered at home, video training, on-demand video or voice calls | No SAE, most common side effects were headache, skin redness, tingling. Drop-outs: 26 (13 active: 8 poor compliance < 60% scheduled sessions, 3 withdrawals, 2 of them due to AE; 10 sham: 7 compliance < 60% of scheduled sessions, 1 AE, 1 patients request, 1 non-compliance) |
Changes from baseline to week 2,4, 6 in the HDRS-score between groups over time time-group interaction for the HDRS-17 were not statistically significant |
S: active and sham condition, regular visits. W: no follow-up |
A = yes Q = no S = yes, only every 2 weeks T = no V = yes |
MADRS Montgomery Asberg Depression Rating Scale, QIDS-SR Quick Inventory of Depressive Symptomatology self-report, QLESQ-SF Quality of Life Enjoyment and Satisfaction Questionnaire–Short Form