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Exercise and Brain Stimulation for Post-stroke Depression

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aerobic exercise

Repetitive transcranial magnetic stimulation

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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;
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; 15) currently exercising ≥ 2 times per week (≥20 minutes);

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

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Arm Label

Aerobic Exercise

rTMS

AET+rTMS

Sham

Arm Description

Treadmill aerobic exercise

repetitive transcranial magnetic stimulation

Combined aerobic exercise and rTMS

Sham rTMS

Outcomes

Primary Outcome Measures

Change from baseline in Hamilton Rating Scale for Depression

Rating of depressive symptom severity

Secondary Outcome Measures

Change from baseline in Self-selected walking speed

Full Information

NCT ID

NCT03056287

First Posted

February 8, 2017

Last Updated

March 3, 2020

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT03056287

Brief Title

Exercise and Brain Stimulation for Post-stroke Depression

Official Title

Treating Depression and Enhancing Locomotor Recovery Post-stroke

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aerobic Exercise

Arm Type

Experimental

Arm Description

Treadmill aerobic exercise

Arm Title

rTMS

Arm Type

Experimental

Arm Description

repetitive transcranial magnetic stimulation

Arm Title

AET+rTMS

Arm Type

Experimental

Arm Description

Combined aerobic exercise and rTMS

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

Sham rTMS

Intervention Type

Behavioral

Intervention Name(s)

Aerobic exercise

Intervention Description

treadmill aerobic exercise; 3 sessions per week, 40 minutes per session

Intervention Type

Other

Intervention Name(s)

Repetitive transcranial magnetic stimulation

Other Intervention Name(s)

rTMS

Intervention Description

Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.

Primary Outcome Measure Information:

Title

Change from baseline in Hamilton Rating Scale for Depression

Description

Rating of depressive symptom severity

Time Frame

weekly throughout the 8 week intervention as well as at the 8 week follow-up visit

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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: 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; 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; 15) currently exercising ≥ 2 times per week (≥20 minutes); 16) Presence of non-MR compatible implants, pregnancy or severe claustrophobia.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chris M Gregory, PhD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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