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Exercise and Brain Stimulation for Post-stroke Depression

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ClinicalTrials.gov Identifier: NCT03056287
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Chris Gregory, Medical University of South Carolina

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stroke Behavioral: Aerobic exercise Other: Repetitive transcranial magnetic stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Depression and Enhancing Locomotor Recovery Post-stroke
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Exercise
Treadmill aerobic exercise
Behavioral: Aerobic exercise
treadmill aerobic exercise; 3 sessions per week, 40 minutes per session

Experimental: rTMS
repetitive transcranial magnetic stimulation
Other: Repetitive transcranial magnetic stimulation
Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
Other Name: rTMS

Experimental: AET+rTMS
Combined aerobic exercise and rTMS
Behavioral: Aerobic exercise
treadmill aerobic exercise; 3 sessions per week, 40 minutes per session

Other: Repetitive transcranial magnetic stimulation
Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
Other Name: rTMS

Sham Comparator: Sham
Sham rTMS
Other: Repetitive transcranial magnetic stimulation
Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
Other Name: rTMS




Primary Outcome Measures :
  1. Change from baseline in Hamilton Rating Scale for Depression [ Time Frame: weekly throughout the 8 week intervention as well as at the 8 week follow-up visit ]
    Rating of depressive symptom severity


Secondary Outcome Measures :
  1. Change from baseline in Self-selected walking speed [ Time Frame: weekly throughout the 8 week intervention as well as at the 8 week follow-up visit ]


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) age 50-70
  • 2) stroke within the past 6 to 60 months,
  • 3) 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),
  • 4) residual paresis in the lower extremity (Fugl-Meyer LE motor score <34),
  • 5) ability to walk without assistance and without an AFO on the treadmill ≥ 30 seconds at speeds ranging from 0.2-0.8 m/s,
  • 6) no antidepressant medications or clinically able to discontinue medications,
  • 7) HRSD question #9 regarding suicide <2,
  • 8) 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.

Exclusion Criteria:

  1. Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking;
  2. history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's;
  3. History of oxygen dependence;
  4. Preexisting neurological disorders, dementia or previous stroke;
  5. History of major head trauma;
  6. Legal blindness or severe visual impairment;
  7. history of psychosis or other Axis I disorder that is primary;
  8. Life expectancy <1 yr.;
  9. Severe arthritis or other problems that limit passive range of motion;
  10. History of DVT or pulmonary embolism within 6 months;
  11. Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
  12. Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest;
  13. attempt of suicide in the last 2 years or at suicidal risk assessed by SCID interview;
  14. Previous or current enrollment in a clinical trial to enhance motor recovery; 15) currently exercising ≥ 2 times per week (≥20 minutes);

16) Presence of non-MR compatible implants, pregnancy or severe claustrophobia.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056287


Contacts
Contact: Chris M Gregory, PhD 8437921078 gregoryc@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Chris M Gregory, PhD    843-792-1078    gregoryc@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Chris M Gregory, PhD Medical University of South Carolina

Responsible Party: Chris Gregory, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03056287     History of Changes
Other Study ID Numbers: COBRE: EXD
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Depression
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms