Table II.
Ongoing clinical trial in AD patients' treatment with TMS.
| Trial no. (www.clinicaltrials.gov) | Study type | Study Samples to be Enroll | Disease | Aim | Active group treatment protocol | Control group treatment |
|---|---|---|---|---|---|---|
| NCT03121066 | Randomized Clinical Trial | 45 | AD | Impact on cognitive and emotional functioning, functionality, and brain connectivity | iTBS protocol: 1,200 pulses per session for 3.12 min | Sham TMS |
| NCT03224988 | Prospective, observational, case-control study | 60 | Pre-clinical AD (aMCI or MCI-AD) | To establish the structural basis for bilateral brain interactions and the temporal dynamics of cross-hemispheric communication in in MCI-AD patients or healthy patients using unilateral or bilateral TMS. | Single-pulse TMS, dual-coil TMS and EEG | Single-pulse TMS, dual-coil TMS and EEG over healthy patients |
| NCT03846492 | Double blinded Randomized Clinical Trial | 90 | AD + Agitation (mild to moderate agitation) | To assess the mechanisms and treatment of AD and cortical excitation/inhibition balance in the DPLFC in AD | tDCS: The direct current will be delivered at 2 mA for 30 min per day for 2 weeks, 5 days/week. Inhibitory stimulation will be delivered to the frontal lobes. | Sham tDCS on healthy comparators |
| NCT04260724 | Interventional, Prospective, Randomized, Evaluator-blind, Single Center Study | 32 | Mild to Moderate AD patients | To assess the change of cognition, mood, ADL, brain structural and functional MRI following TMS | TMS: 1,600 pulses for 20 min per day, for 4 weeks (5 days per week) | Sham TMS (no stimulation) |
| NCT04294888 | Randomized Clinical Trial | 40 | aMCI due to AD | To evaluate changes in functional network architecture following rTMS treatment | Excitatory iTBS pattern | Sham rTMS |
| NCT04555941 | Randomized Clinical Trial | 60 | Mild cognitive impairment or early dementia due to Alzheimer's disease | To assess the cognitive functions | iTBS: 10 sessions, 80% Resting Motor Threshold, 2s stimulation 8s inter-stimulus interval per train, 20 trains per block, 3 blocks per session with a 5-min break, 1 session per day | Sham iTBS to the patients |
| NCT04823819 | Randomized Clinical Trial | 40 | Mild to moderate AD | Effectiveness and safety of rTMS + tDCS on long and short term cognitive functions | rTMS stimulation: 20 sessions of stimulation with increasing intensity, reaching maximum in the 4th session over the left DLPFC | Sham rTMS & Sham tDCS |
| NCT04866979 | Double blinded Randomized Clinical Trial | 200 | MCI & AD | To evaluate the clinical efficacy of TBS in conjunction with CT. | Combination of cTBS + CT; combination of iTBS + CT; cTBS; iTBS TBS delivery of 600 pulses divided into blocks of 3 pulses at 50 Hz, which are applied at 5 Hz (every 200 ms), with a stimulation intensity equal to 80% of the motor threshold value at rest | Cognitive training only (with placebo TBS) |
AD, Alzheimer's disease; ADL, activity of daily life; aMCI, amnestic mild cognitive impairments; CT, cognitive training; cTBS, continuous theta burst stimulation; DPLFC, dorsolateral prefrontal cortex; EEG, Electroencephalography; Hz, Hertz; iTBS, Intermittent theta burst stimulation; rTMS, repetitive transcranial magnetic stimulation; TBS, theta burst stimulation; TMS, transcranial magnetic stimulation.