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

NCT07652775 | Recruiting

• 1 other identifier: (1184)114-42
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment (MCI); Depressive Symptoms

Keywords

Repetitive Transcranial Magnetic Stimulation; Aerobic Exercise; Dual-Task Walking; Timed Up and Go; Cognitive Function; Older Adults; Life Satisfaction; Gait Performance; rTMS

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  Changes in global cognitive function measured using the Montreal Cognitive Assessment (MoCA). Higher scores indicate better cognitive performance.

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

Secondary Outcomes (21)

• Geriatric Depression Scale-15 (GDS-15)

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

• Pittsburgh Sleep Quality Index (PSQI)

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

• Trail Making Test Part A (TMT-A)

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

• Trail Making Test Part B (TMT-B)

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

• California Verbal Learning Test-Short Form (CVLT-SF)

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

Study Arms (3)

rTMS Alone

EXPERIMENTAL

Participants receive active repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (DLPFC). Stimulation sessions are conducted 4 times per week for 5 weeks (20 sessions total).

Device: Repetitive Transcranial Magnetic Stimulation

rTMS Combined With Aerobic Exercise

EXPERIMENTAL

Participants receive active repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (DLPFC), immediately followed by 30 minutes of moderate-intensity stationary cycling exercise. Sessions are conducted 4 times per week for 5 weeks (20 sessions total).

Device: Repetitive Transcranial Magnetic Stimulation; Behavioral: Aerobic Exercise

Sham rTMS Combined With Aerobic Exercise

EXPERIMENTAL

Participants receive sham repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (DLPFC), immediately followed by 30 minutes of moderate-intensity stationary cycling exercise. Sham stimulation is delivered using a figure-of-eight coil positioned at a 90-degree angle relative to the scalp and approximately 3 cm from the scalp surface to mimic the sensory and auditory experience of active stimulation without inducing effective cortical activation. Sessions are conducted 4 times per week for 5 weeks (20 sessions total).

Behavioral: Aerobic Exercise; Device: Sham Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

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).

Also known as: rTMS

rTMS Alone; rTMS Combined With Aerobic Exercise

Aerobic Exercise BEHAVIORAL

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).

Sham rTMS Combined With Aerobic Exercise; rTMS Combined With Aerobic Exercise

Sham Repetitive Transcranial Magnetic Stimulation DEVICE

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).

Sham rTMS Combined With Aerobic Exercise

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 to 90 years.
• Diagnosed with mild cognitive impairment (MCI) according to established clinical criteria.
• Presence of depressive symptoms as determined by clinical assessment and Beck Depression Inventory-II (BDI-II).
• Able to communicate and follow study instructions.
• Able to ambulate independently with or without an assistive device.
• Able to provide written informed consent.

You may not qualify if:

• Diagnosis of dementia.
• History of epilepsy or seizure disorder.
• Presence of metallic implants, pacemakers, cochlear implants, or other contraindications to transcranial magnetic stimulation.
• Major neurological disorders, including stroke, Parkinson's disease, traumatic brain injury, or other neurodegenerative diseases.
• Severe psychiatric disorders other than depression.
• Severe cardiovascular, musculoskeletal, or medical conditions that preclude participation in aerobic exercise.
• Severe visual or hearing impairments that interfere with cognitive assessment.
• Current participation in another intervention study.

Sponsors & Collaborators

• Cheng-Hsin General Hospital: lead

Study Sites (1)

Cheng Hsin General Hospital

Taipei, Taipei City, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Depression; Personal Satisfaction

Interventions

Transcranial Magnetic Stimulation; Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kai-Chen Wang, MD

  Cheng-Hsin General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Chu Chan, MS Candidate

CONTACT

+886-983-559-807; aya45285@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. Sham stimulation will be delivered using a figure-of-eight coil positioned at a 90-degree angle to the scalp and approximately 3 cm away from the scalp surface to mimic the auditory and sensory experience of active stimulation without producing effective cortical stimulation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 17, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)