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NCT03056287 · ClinicalTrials.gov registry record · NA

Exercise and Brain Stimulation for Post-stroke Depression

A NA study of Stroke, sponsored by Medical University of South Carolina.

Completed
Registry status
NA
Development phase
23
Enrollment target
1
Study location

NCT03056287 is a NA study of Stroke that has completed, run by Medical University of South Carolina. The registered enrollment target is 23 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03056287, a NA study of Stroke, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
NA
Development phase
23 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • BEHAVIORAL Aerobic exercise
  • OTHER Repetitive transcranial magnetic stimulation

Study Locations (1)

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2016-01-01
Est. Completion 2019-12-31
Phase NA

What the Registry Record Tells You About NCT03056287

The ClinicalTrials.gov registry entry for NCT03056287 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Aerobic exercise is the first listed.

NCT03056287 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.

Frequently Asked Questions

What is clinical trial NCT03056287 about?

NCT03056287 is a clinical study titled "Exercise and Brain Stimulation for Post-stroke Depression". 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 treatment...

What is the current status of trial NCT03056287?

This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2016-01-01. Estimated completion is 2019-12-31.

What conditions does trial NCT03056287 study?

This clinical trial studies the following conditions: Stroke.

What interventions are being tested in trial NCT03056287?

The interventions under investigation include: Aerobic exercise (BEHAVIORAL), Repetitive transcranial magnetic stimulation (OTHER).

Who is sponsoring clinical trial NCT03056287?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03056287 being conducted?

This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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