Recruiting

rTMS Combined With Aerobic Exercise for Older Adults With Mild Cognitive Impairment and Comorbid Depression

ClinicalTrials.gov IDNCT07652775

PhaseNA

Enrollment45

SponsorCheng-Hsin General Hospital

Age65 Years

SexALL

I'm interested View official listing

Conditions studied

Mild Cognitive Impairment (MCI), Depressive Symptoms

About this study

This study aims to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) and aerobic exercise on cognitive function and mental health in older adults with mild cognitive impairment (MCI) and comorbid depression. Forty-five participants will be randomly assigned to one of three groups: (1) rTMS alone, (2) rTMS combined with stationary cycling exercise, or (3) sham rTMS combined with stationary cycling exercise. Participants will receive 20 intervention sessions over a 5-week period (4 sessions per week). Outcomes, including cognitive function, depressive symptoms, sleep quality, life satisfaction, self-efficacy, and gait performance, will be assessed at baseline, immediately after completion of the 5-week intervention, and at a 1-month follow-up. The findings may contribute to the development of evidence-based, non-pharmacological interventions for improving cognitive and mental health outcomes in older adults with MCI and comorbid depression.

Interventions

Device: Repetitive Transcranial Magnetic Stimulation — Active repetitive transcranial magnetic stimulation (rTMS) is delivered over the left dorsolateral prefrontal cortex (DLPFC) using a figure-of-eight coil. Participants receive stimulation sessions 4 times per week for 5 weeks (20 sessions total).
Behavioral: Aerobic Exercise — Participants perform 30 minutes of moderate-intensity stationary cycling exercise immediately following rTMS or sham rTMS sessions. Exercise sessions are conducted 4 times per week for 5 weeks (20 sessions total).
Device: Sham Repetitive Transcranial Magnetic Stimulation — Sham stimulation is delivered using a figure-of-eight coil positioned at a 90-degree angle relative to the scalp and approximately 3 cm away from the scalp surface to mimic the sensory and auditory experience of active stimulation without producing effective cortical activation. Participants receive sham stimulation sessions 4 times per week for 5 weeks (20 sessions total).

Primary outcomes

Montreal Cognitive Assessment (MoCA) (Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion))

Eligibility information

Inclusion Criteria: 1. Aged 65 to 90 years. 2. Diagnosed with mild cognitive impairment (MCI) according to established clinical criteria. 3. Presence of depressive symptoms as determined by clinical assessment and Beck Depression Inventory-II (BDI-II). 4. Able to communicate and follow study instructions. 5. Able to ambulate independently with or without an assistive device. 6. Able to provide written informed consent. Exclusion Criteria: 1. Diagnosis of dementia. 2. History of epilepsy or seizure disorder. 3. Presence of metallic implants, pacemakers, cochlear implants, or other contraindications to transcranial magnetic stimulation. 4. Major neurological disorders, including stroke, Parkinson's disease, traumatic brain injury, or other neurodegenerative diseases. 5. Severe psychiatric disorders other than depression. 6. Severe cardiovascular, musculoskeletal, or medical conditions that preclude participation in aerobic exercise. 7. Severe visual or hearing impairments that interfere with cognitive assessment. 8. Current participation in another intervention study.

Study locations

Cheng Hsin General Hospital, Taipei, Taipei City 112 Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.