Purpose of this Study
If you choose to join this study, you will first give your permission and take part in some starting tests. These include answering questions, doing fitness checks, and completing movement tasks. After that, you will be randomly placed into one of three groups: one group will do aerobic exercise, another will receive brain stimulation called rTMS, and the third group will do both.
Each group will follow a 12-week treatment plan. After that, there will be follow-up check-ins at 12 weeks and again at 24 weeks. The entire study will last about 9 months.
Who Can Participate?
Eligibility
To take part in this study, people must be between 21 and 70 years old. They must have had a stroke sometime in the past 1 to 5 years and show signs of depression based on standard tests. They also need to have some weakness or trouble moving in one or both legs but still be able to walk on their own at a slow to moderate pace.
Participants must not be taking antidepressants, or if they are, their dose must have stayed the same for at least a month and their condition must be stable.
Age Range
21-70
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The RESTORATION study is exploring new ways to help people with depression after a stroke. Instead of using medicine, the study is testing whether regular aerobic exercise and a brain treatment called transcranial magnetic stimulation, or TMS, might work better when used together. The goal is to find out if this combination can help people feel better and recover more fully.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Combining rTMS & aerobic exercise to treat depression and improve post-stroke walking
Principal Investigator
Wuwei
Feng
Protocol Number
PRO00116685
NCT ID
NCT07050355
Enrollment Status
Open to Enrollment