Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT07298460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stimulation-based Therapy to Improve Balance in DCM
Sponsor:
Medical College of Wisconsin
Organization:
Study Overview
Official Title:
Transcutaneous Spinal Cord Stimulation to Improve Postural Stability After Surgery for Degenerative Cervical Myelopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
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:
STIM-DCM
Brief Summary:
The goal of this clinical trial is to determine if a treatment called transcutaneous spinal cord stimulation (tSCS), when combined with balance training, can help improve balance in adults who have had surgery for degenerative cervical myelopathy (DCM). DCM is a condition that affects the spinal cord in the neck and often causes problems with walking and balance, even after surgery.
This study will also look at how tSCS affects the nervous system and whether it is safe and practical to use in this group of patients. The results will help researchers plan a larger study in the future.
Main Questions:
* Does tSCS combined with balance training improve balance more than balance training alone?
* Does stimulation at both the neck and mid-back work better than stimulation at the mid-back only?
* What changes in nerve and muscle activity occur with tSCS?
What will happen in this study:
* Participants will be randomly assigned to one of three groups:
1. tSCS applied to the mid-back (thoracic area) plus balance training
2. tSCS applied to both the neck and mid-back (combined stimulation) plus balance training
3. Sham stimulation (electrodes placed but no stimulation) plus balance training
* All participants will complete 12 sessions over 4 weeks (3 sessions per week).
* Each session will include 30 minutes of balance training and 30 minutes of walking exercises.
* Participants will receive stimulation or sham treatment during these sessions.
* Balance and walking tests will be done before and after the program.
* Nerve and muscle activity will also be measured at the same time points.
This pilot study will help determine if tSCS is effective and safe, and will provide information needed to design a larger trial.
This study will also look at how tSCS affects the nervous system and whether it is safe and practical to use in this group of patients. The results will help researchers plan a larger study in the future.
Main Questions:
* Does tSCS combined with balance training improve balance more than balance training alone?
* Does stimulation at both the neck and mid-back work better than stimulation at the mid-back only?
* What changes in nerve and muscle activity occur with tSCS?
What will happen in this study:
* Participants will be randomly assigned to one of three groups:
1. tSCS applied to the mid-back (thoracic area) plus balance training
2. tSCS applied to both the neck and mid-back (combined stimulation) plus balance training
3. Sham stimulation (electrodes placed but no stimulation) plus balance training
* All participants will complete 12 sessions over 4 weeks (3 sessions per week).
* Each session will include 30 minutes of balance training and 30 minutes of walking exercises.
* Participants will receive stimulation or sham treatment during these sessions.
* Balance and walking tests will be done before and after the program.
* Nerve and muscle activity will also be measured at the same time points.
This pilot study will help determine if tSCS is effective and safe, and will provide information needed to design a larger trial.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: