Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-05
Brief Title:
Deep Brain Stimulation of the Dentate Nucleus for Motor Rehabilitation After Stroke
Sponsor:
Beijing Municipal Administration of Hospitals
Organization:
Beijing Municipal Administration of Hospitals
Study Overview
Official Title:
Deep Brain Stimulation of Cerebellar Dentate Nucleus Promotes Upper Limb Motor Function Recovery After Ischemic Stroke a Randomized Double-blind Sham-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The goal of this clinical trial is to learn if deep brain stimulation of the dentate nucleus DN-DBS works to promote chronic post-stroke upper limb motor function in adults It will also learn about the safety of DN-DBS The main questions it aims to answer are
Does DN-DBS paired with rehabilitation improve the upper limb motor function of participants more than rehabilitation only What medical problems do participants have when using DN-DBS for post-stroke rehabilitation
Researchers will compare real DN-DBSrehabilitation to sham DN-DBSrehabilitation electrodes will be implanted but no electrical current is given to see if DN-DBS works to promote chronic post-stroke upper limb motor function
Participants will
Undergo unilateral DN-DBS surgery Take real DN-DBSrehabilitation or sham DN-DBSrehabilitation as treatment for 6 months Visit the clinic every month during the DN-DBSrehabilitation treatment period for programing checkups and tests Visit the clinic at Day 1 30 90 and 365 after treatment period for checkups and tests
Does DN-DBS paired with rehabilitation improve the upper limb motor function of participants more than rehabilitation only What medical problems do participants have when using DN-DBS for post-stroke rehabilitation
Researchers will compare real DN-DBSrehabilitation to sham DN-DBSrehabilitation electrodes will be implanted but no electrical current is given to see if DN-DBS works to promote chronic post-stroke upper limb motor function
Participants will
Undergo unilateral DN-DBS surgery Take real DN-DBSrehabilitation or sham DN-DBSrehabilitation as treatment for 6 months Visit the clinic every month during the DN-DBSrehabilitation treatment period for programing checkups and tests Visit the clinic at Day 1 30 90 and 365 after treatment period for checkups and tests
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