StrokeNCT03056287

Exercise and Brain Stimulation for Post-stroke Depression

A study testing Aerobic exercise and Repetitive transcranial magnetic stimulation in people with Stroke, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 70 years
Conditions the study is for: Stroke
What is being tested?: Aerobic exercise and Repetitive transcranial magnetic stimulation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2016to 31 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age 50-70
stroke within the past 6 to 60 months,
major depressive disorder (PHQ-9 > 10) and diagnosed using the Structured Clinical Interview for Depression (SCID) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV),
residual paresis in the lower extremity (Fugl-Meyer LE motor score <34),
ability to walk without assistance and without an AFO on the treadmill ≥ 30 seconds at speeds ranging from 0.2-0.8 m/s,
no antidepressant medications or clinically able to discontinue medications,
HRSD question #9 regarding suicide <2,
provision of informed consent. In addition, all subjects who meet criteria for the training portion must complete an exercise tolerance test and be cleared for participation by the study cardiologist.

Who cannot join

Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking;
history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's;
History of oxygen dependence;
Preexisting neurological disorders, dementia or previous stroke;
History of major head trauma;
Legal blindness or severe visual impairment;

Show all 16Show fewer

history of psychosis or other Axis I disorder that is primary;
Life expectancy <1 yr.;
Severe arthritis or other problems that limit passive range of motion;
History of DVT or pulmonary embolism within 6 months;
Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest;
attempt of suicide in the last 2 years or at suicidal risk assessed by SCID interview;
Previous or current enrollment in a clinical trial to enhance motor recovery;
currently exercising ≥ 2 times per week (≥20 minutes);
Presence of non-MR compatible implants, pregnancy or severe claustrophobia.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Treating Depression and Enhancing Locomotor Recovery Post-stroke

This project will assess the effects of aerobic exercise training (AET), repetitive transcranial magnetic stimulation (rTMS) or their combination on depressive severity as well as locomotor function in persons with post-stroke depression (PSD). Both AET and rTMS are established stand-alone treatments for non-stroke related depression, though neither has been adequately studied post-stroke. Furthermore, substantive research indicates that AET improves post-stroke locomotor function, thus offering a novel approach for treating PSD as well as an established vehicle to study the effects of PSD on response to rehabilitation.

The purpose of this project is to determine the impact of AET, rTMS and their combination (AET+rTMS) treatments on post-stroke depressive symptoms and locomotor function so as to guide the development of a future clinical trial. A total of 40 depressed post-stroke subjects will be randomly assigned to one of four groups 1) AET; 2) rTMS; 3) combined AET and rTMS (AET+rTMS) or 4) control (sham rTMS) group (n=10 per condition; equally distributed with mild and moderate MDD). Further, an additional 10 non-depressed post-stroke subjects will complete 8 weeks of AET so as to allow us to determine the effects of PSD on response to training (Aim 2). Training (AET, rTMS and AET+rTMS) will take place over an 8-week period, three times per week on non-consecutive days. Measures of depression (HRSD17) as well as self-selected walking speed (SSWS) will be performed prior to the initial treatment session of each week as well as 8 weeks following cessation of treatment. Additional measures of locomotor function (walking endurance and amount of daily community stepping) will be assessed prior to training (pre), following 4 weeks of training (mid), upon completion of 8 weeks of training (post) as well as 8 weeks following cessation of training (follow-up), allowing determination of the efficacy (and persistence) of training on these outcomes.

Conditions: Stroke
Being tested: Aerobic exercise, Repetitive transcranial magnetic stimulation
Medical subject headings: Stroke

What participants receive

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

Aerobic exerciseBehavioural
treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
Repetitive transcranial magnetic stimulationOther
Also called rTMS
Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.

Study groups in NCT03056287
Study group	Role	What they receive
Aerobic Exercise	Experimental	Treadmill aerobic exercise Receives: Behavioral: Aerobic exercise
rTMS	Experimental	repetitive transcranial magnetic stimulation Receives: Other: Repetitive transcranial magnetic stimulation
AET+rTMS	Experimental	Combined aerobic exercise and rTMS Receives: Behavioral: Aerobic exercise; Other: Repetitive transcranial magnetic stimulation
Sham	Sham comparator	Sham rTMS Receives: Other: Repetitive transcranial magnetic stimulation

What is being measured

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

Change From Baseline to Post Training in Hamilton Rating Scale for Depression
The Hamilton Rating Scale for Depression is a clinician-administered depression assessment scale containing 17 items pertaining to symptoms of depression experienced over the past week. A total score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a total score of 20 or higher indicates at least moderate severity depression. Score range 0-58. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.
Measured: assessed at baseline and weekly throughout the 8 week intervention. Change from baseline to week 8 reported as primary outcome

Secondary outcomes (1)

Change From Baseline to Week 8 in Self-selected Walking Speed
Measured: assessed at baseline as well as weekly throughout the 8 week intervention. Change from baseline to week 8 reported as outcome

Timeline

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

1 Jan 201631 Dec 2019

First posted17 Feb 2017
Study start1 Jan 2016
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Factorial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03056287
Sponsor's protocol ID: COBRE: EXD
Status last verified: May 2025
First submitted: 8 Feb 2017
Last updated: 14 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
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OPTION-EMEA Clinical Trial
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Metformin in Acute Ischemic Stroke
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Music Therapy in Post-Stroke Patients: A Clinical Trial
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treating Depression and Enhancing Locomotor Recovery Post-stroke
ClinicalTrials.gov ID: NCT03056287
Acronym / sponsor ID: COBRE: EXD
Conditions: Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 1 Jan 2016 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 17 Feb 2017 (actual)
Results: Posted 14 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Aerobic Exercise	Experimental	Behavioral: Aerobic exerciseTreadmill aerobic exercise
rTMS	Experimental	Other: Repetitive transcranial magnetic stimulationrepetitive transcranial magnetic stimulation
AET+rTMS	Experimental	Behavioral: Aerobic exercise, Other: Repetitive transcranial magnetic stimulationCombined aerobic exercise and rTMS
Sham	Sham comparator	Other: Repetitive transcranial magnetic stimulationSham rTMS

Who may qualify

Ages: 50 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

age 50-70
stroke within the past 6 to 60 months,
major depressive disorder (PHQ-9 > 10) and diagnosed using the Structured Clinical Interview for Depression (SCID) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV),
residual paresis in the lower extremity (Fugl-Meyer LE motor score <34),
ability to walk without assistance and without an AFO on the treadmill ≥ 30 seconds at speeds ranging from 0.2-0.8 m/s,

Key exclusion criteria (16 listed)

Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking;
history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's;
History of oxygen dependence;
Preexisting neurological disorders, dementia or previous stroke;
History of major head trauma;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aerobic exercisetreadmill aerobic exercise; 3 sessions per week, 40 minutes per session	Behavioural	AET+rTMS, Aerobic Exercise
Repetitive transcranial magnetic stimulationAlso: rTMSRepeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.	Other	AET+rTMS, Sham, rTMS

Primary outcome

Change From Baseline to Post Training in Hamilton Rating Scale for Depression
Time frame: assessed at baseline and weekly throughout the 8 week intervention. Change from baseline to week 8 reported as primary outcome
The Hamilton Rating Scale for Depression is a clinician-administered depression assessment scale containing 17 items pertaining to symptoms of depression experienced over the past week. A total score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a total score of 20 or higher indicates at least moderate severity depression. Score range 0-58. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.

1 secondary outcome

Change From Baseline to Week 8 in Self-selected Walking Speed
Time frame: assessed at baseline as well as weekly throughout the 8 week intervention. Change from baseline to week 8 reported as outcome

Results and safety

Results posted to the registry on 14 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aerobic Exercise	4	4
rTMS	6	5
AET+rTMS	6	5
Sham	7	6

Primary outcome: Change From Baseline to Post Training in Hamilton Rating Scale for Depression

Time frame: assessed at baseline and weekly throughout the 8 week intervention. Change from baseline to week 8 reported as primary outcome. Mean (Standard Deviation). Unit: units on a scale

Measure	Aerobic Exercise n = 4	rTMS n = 6	AET+rTMS n = 6	Sham n = 7
Value	-2.75 (4.5)	-7.5 (5.46)	-7.83 (4.49)	-2.29 (2.63)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Throughout the 8 week intervention as well as during an 8 week follow-up period. Collected over a total of weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aerobic Exercise	0 of 4 (0%)	1 of 4 (25%)	0 of 4
rTMS	0 of 6 (0%)	0 of 6 (0%)	0 of 6
AET+rTMS	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Sham	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
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Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Recruiting
Music Therapy in Post-Stroke Patients: A Clinical Trial
CVA (Cerebrovascular Accident), Ictus
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chris M Gregory, PhD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise and Repetitive transcranial magnetic stimulation in people with Stroke, run by Medical University of South Carolina at 1 site in United States.

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 8 inclusion and 16 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: finished, as of the sponsor's last update on 14 May 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Post Training in Hamilton Rating Scale for Depression (time frame: assessed at baseline and weekly throughout the 8 week intervention. Change from baseline to week 8 reported as primary outcome). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03056287.

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 14 May 2025.