rTMS Combined With Aerobic Exercise for Older Adults With Mild Cognitive Impairment and Comorbid Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorCheng-Hsin General Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation
DeviceActive 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 Exercise
BehavioralParticipants 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 Stimulation
DeviceSham 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).
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: rTMS AloneExperimental treatment 1 intervention
Group B: rTMS Combined With Aerobic ExerciseExperimental treatment 2 interventions
Group C: Sham rTMS Combined With Aerobic ExerciseExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov