Ignite Creation Date:
2024-05-06 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03056287
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2017-02-08
Brief Title:
Exercise and Brain Stimulation for Post-stroke Depression
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Treating Depression and Enhancing Locomotor Recovery Post-stroke
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 AETrTMS 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 AETrTMS or 4 control sham rTMS group n10 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 AETrTMS 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
The purpose of this project is to determine the impact of AET rTMS and their combination AETrTMS 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 AETrTMS or 4 control sham rTMS group n10 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 AETrTMS 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None