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Mild Cognitive Impairment (MCI)NCT07652775

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

A study testing Repetitive Transcranial Magnetic Stimulation and Aerobic Exercise in people with Mild Cognitive Impairment (MCI) and Depressive Symptoms, run by Cheng-Hsin General Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 90 years
What is being tested?
Repetitive Transcranial Magnetic Stimulation and Aerobic Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteTaiwan
Study dates
3 Mar 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ya-Chu Chan, MS Candidate contact

+886-983-559-807

aya45285@gmail.com

Taiwan1 site, 1 recruiting
  • Cheng Hsin General Hospital

    Taipei, Taipei City, 112

    Ya-Chu Chan, MS Candidate, +886-983-559-807, aya45285@gmail.com

    Kai-Chen Chan, MD, +886-983-559-807, aya45285@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Effects of Repetitive Transcranial Magnetic Stimulation Combined With Aerobic Exercise on Cognitive Function, Psychological Health, and Walking Performance in Older Adults With Mild Cognitive Impairment and Comorbid Depression: A Randomized Controlled Trial

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.

Read the detailed description

Mild cognitive impairment (MCI) is a transitional stage between normal aging and dementia and is frequently accompanied by depressive symptoms. Older adults with MCI and comorbid depression are at increased risk of cognitive decline, functional impairment, reduced quality of life, and progression to dementia. Therefore, effective non-pharmacological interventions targeting both cognitive and mental health outcomes are needed.

This study aims to investigate the effects of rTMS alone and rTMS combined with aerobic exercise on cognitive and mental health outcomes in older adults with MCI and comorbid depression. A randomized controlled trial design will be employed. Forty-five eligible participants who provide written informed consent will be randomly assigned to one of three groups: (1) rTMS alone, (2) rTMS combined with stationary cycling exercise, and (3) sham rTMS combined with stationary cycling exercise.

All participants will receive 20 intervention sessions over a 5-week intervention period (4 sessions per week). Intervention sessions will be conducted on Monday, Tuesday, Thursday, and Friday. Participants in the rTMS-alone group will receive a 5-minute rTMS session only. Participants in the rTMS combined with stationary cycling exercise group and the sham rTMS combined with stationary cycling exercise group will receive either active or sham rTMS for 5 minutes, followed by 30 minutes of stationary cycling exercise.

The stimulation target will be the left dorsolateral prefrontal cortex (DLPFC). For sham stimulation, a figure-of-eight coil will be positioned with one wing angled at 90 degrees relative to the scalp and maintained approximately 3 cm from the scalp surface to mimic the sensory experience of active stimulation while minimizing effective cortical stimulation.

Outcome assessments will be conducted at baseline, immediately after completion of the 5-week intervention period, and at a 1-month follow-up. Outcome measures will include cognitive function, depressive symptoms, sleep quality, life satisfaction, self-efficacy, and gait performance. Each assessment session is expected to require approximately 45 minutes.

The findings may provide evidence supporting the application of combined neuromodulation and aerobic exercise interventions for improving cognitive and mental health outcomes in older adults with MCI and comorbid depression.

Being tested
Repetitive Transcranial Magnetic Stimulation, Aerobic Exercise, Sham Repetitive Transcranial Magnetic Stimulation
Keywords
Repetitive Transcranial Magnetic Stimulation, Aerobic Exercise, Dual-Task Walking, Timed Up and Go, Cognitive Function, Older Adults, Life Satisfaction, Gait Performance, rTMS
Medical subject headings
Cognitive Dysfunction, Depression, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repetitive Transcranial Magnetic StimulationDevice

    Also called rTMS

    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).

  • Aerobic ExerciseBehavioural

    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 Repetitive Transcranial Magnetic StimulationDevice

    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).

Study groups in NCT07652775
Study groupRoleWhat they receive
rTMS AloneExperimentalParticipants 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).
Receives: Device: Repetitive Transcranial Magnetic Stimulation
rTMS Combined With Aerobic ExerciseExperimentalParticipants 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).
Receives: Device: Repetitive Transcranial Magnetic Stimulation; Behavioral: Aerobic Exercise
Sham rTMS Combined With Aerobic ExerciseExperimentalParticipants 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).
Receives: Behavioral: Aerobic Exercise; Device: Sham Repetitive Transcranial Magnetic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montreal Cognitive Assessment (MoCA)

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

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

Secondary outcomes (21)
  1. Geriatric Depression Scale-15 (GDS-15)

    Changes in depressive symptoms measured using the Geriatric Depression Scale-15 (GDS-15). Higher scores indicate greater depressive symptom severity.

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

  2. Pittsburgh Sleep Quality Index (PSQI)

    Changes in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Lower scores indicate better sleep quality.

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

  3. Trail Making Test Part A (TMT-A)

    Changes in attention and processing speed measured using the Trail Making Test Part A. Shorter completion times indicate better performance.

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

  4. Trail Making Test Part B (TMT-B)

    Shorter completion times indicate better executive functioning and cognitive flexibility.

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

  5. California Verbal Learning Test-Short Form (CVLT-SF)

    Changes in verbal learning and memory measured using the California Verbal Learning Test-Short Form (CVLT-SF). Higher scores indicate better verbal learning and memory performance.

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

  6. Stroop Color-Word Test

    Changes in executive function, selective attention, and inhibitory control measured using the Stroop Color-Word Test (SCWT). Performance is assessed as the number of correct responses completed within 1 minute. Higher scores indicate better executive function, selective attention, and inhibitory control.

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

  7. Digit Span Forward Test

    Changes in attention span and immediate verbal memory measured using the Digit Span Forward Test. Higher scores indicate better attention and short-term memory performance.

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

  8. Digit Span Backward Test

    Changes in working memory and executive function measured using the Digit Span Backward Test. Higher scores indicate better working memory performance.

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

  9. Beck Depression Inventory-II (BDI-II)

    Higher scores indicate greater depressive symptom severity.

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

  10. EuroQol Five-Dimension Five-Level Questionnaire Index Score (EQ-5D-5L Index)

    Changes in health-related quality of life measured using the EuroQol Five-Dimension Five-Level Questionnaire Index Score (EQ-5D-5L Index). Higher scores indicate better health-related quality of life.

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

  11. World Health Organization Quality of Life-BREF (WHOQOL-BREF)

    Changes in quality of life measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF). Higher scores indicate better quality of life.

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

  12. Chinese Aging Well Profile (CAWP)

    Changes in subjective well-being measured using the Chinese Aging Well Profile (CAWP). Higher scores indicate better subjective well-being.

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

  13. Timed Up and Go Test (TUG)

    Changes in functional mobility measured using the Timed Up and Go Test (TUG). Participants are instructed to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Shorter completion times indicate better functional mobility and balance performance.

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

  14. EuroQol Visual Analogue Scale Score (EQ-VAS)

    Changes in self-rated health status measured using the EuroQol Visual Analogue Scale (EQ-VAS). Higher scores indicate better perceived health status.

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

  15. Dual-task gait speed (m/s)

    Changes in dual-task gait speed measured in meters per second (m/s). Higher values indicate better gait performance.

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

  16. Dual-task cadence (steps/min)

    Changes in dual-task cadence measured in steps per minute. Higher values indicate better gait performance.

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

  17. Dual-task stride length (m)

    Changes in dual-task stride length measured in meters. Higher values indicate better gait performance.

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

  18. Dual-task cost (%)

    Percentage change in gait performance during dual-task walking relative to single-task walking.

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

  19. Single-task gait speed (m/s)

    Walking speed during single-task walking, measured in meters per second.

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

  20. Single-task cadence (steps/min)

    Higher values indicate better gait performance.

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

  21. Single-task stride length (m)

    Higher values indicate better gait performance.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start3 Mar 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07652775
Sponsor's protocol ID
(1184)114-42
Status last verified
Jun 2026
First submitted
7 Jun 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Transcranial Magnetic Stimulation and Aerobic Exercise in people with Mild Cognitive Impairment (MCI) and Depressive Symptoms, run by Cheng-Hsin General Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ya-Chu Chan, MS Candidate (+886-983-559-807, aya45285@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment (MoCA) (time frame: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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