Exercise and Brain Stimulation for Post-stroke Depression

NCT03056287 | Completed Results DMC

• 1 other identifier: COBRE: EXD
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  assessed at baseline as well as weekly throughout the 8 week intervention. Change from baseline to week 8 reported as outcome

Study Arms (4)

Aerobic Exercise

EXPERIMENTAL

Treadmill aerobic exercise

Behavioral: Aerobic exercise

rTMS

EXPERIMENTAL

repetitive transcranial magnetic stimulation

Other: Repetitive transcranial magnetic stimulation

AET+rTMS

EXPERIMENTAL

Combined aerobic exercise and rTMS

Behavioral: Aerobic exercise; Other: Repetitive transcranial magnetic stimulation

Sham

SHAM COMPARATOR

Sham rTMS

Other: Repetitive transcranial magnetic stimulation

Interventions

Aerobic exercise BEHAVIORAL

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

AET+rTMS; Aerobic Exercise

Repetitive transcranial magnetic stimulation OTHER

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

Also known as: rTMS

AET+rTMS; Sham; rTMS

Eligibility Criteria

• Age: 50 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Exercise; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Chris Gregory
• Organization: Medical University of South Carolina

gregoryc@musc.edu

8437921078

Study Officials

• Chris M Gregory, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 17, 2017
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)