Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT07298460
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.
Study:
NCT07298460
Study Brief:
Protocol Section:
NCT07298460