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Recruiting NCT07652775

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

No phase Interventional Mild Cognitive Impairment (MCI) Depressive Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repetitive Transcranial Magnetic Stimulation, Aerobic Exercise, Sham Repetitive Transcranial Magnetic Stimulation.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI), Depressive Symptoms. Basic parameters: 65 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

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 outcome measures

  • 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)]
Secondary outcome measures (12)
  • Geriatric Depression Scale-15 (GDS-15) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)]
  • Stroop Color-Word Test [Time frame: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)]
  • Digit Span Forward Test [Time frame: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)]
  • Digit Span Backward Test [Time frame: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)]
  • Beck Depression Inventory-II (BDI-II) [Time frame: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)]
  • EuroQol Five-Dimension Five-Level Questionnaire Index Score (EQ-5D-5L Index) [Time frame: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)]
  • World Health Organization Quality of Life-BREF (WHOQOL-BREF) [Time frame: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)]
  • Chinese Aging Well Profile (CAWP) [Time frame: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Cheng Hsin General Hospital — Taipei

Identifiers

NCT: NCT07652775 · (1184)114-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗