Exercise and Brain Stimulation for Post-stroke Depression
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 50 - 70 |
| Updated: | 5/6/2018 |
| Start Date: | January 1, 2016 |
| End Date: | December 31, 2020 |
| Contact: | Chris M Gregory, PhD |
| Email: | gregoryc@musc.edu |
| Phone: | 8437921078 |
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.
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.
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.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-1078
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