Efficacy of a Wearable Noninvasive Neuromodulation Device

NANot yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

November 30, 2029

Study Completion Date

November 30, 2029

Conditions
Spinal Cord Injuries
Interventions
DEVICE

TNM at a sham-point (AccelBand) - randomized arm

"This will be self-administrated by study participants (or caregivers) for a period of approximately 4 weeks twice a day (once in the morning and once in the evening daily), each lasting 60 minutes. Scheduled weekly phone calls will be provided by the study team member to assure compliance with the TNM administration and answer any questions that a participant may have.~In addition to the treatment period participants will have tests completed (baseline and following treatment), as well as complete surveys during the trial."

DEVICE

TNM at a leg point (AccelBand)- randomized arm

"This will be self-administrated by study participants (or caregivers) for a period of approximately 4 weeks twice a day (once in the morning and once in the evening daily), each lasting 60 minutes. Scheduled weekly phone calls will be provided by the study team member to assure compliance with the TNM administration and answer any questions that a participant may have.~In addition to the treatment period participants will have tests completed (baseline and following treatment), as well as complete surveys during the trial."

DEVICE

TNM at a leg point (AccelBand)- open-label

After 4 weeks of blinded treatment sham participants will be given the option to continue open-label TNM treatment at a leg point acupoint. Participants that agree to this will be re-trained and allowed to keep the AccelBand for another 2 weeks. During this stage, participants will be asked to complete daily home-based TNM treatment and complete the daily online symptom questionnaires. Participants will complete a visit following this additional treatment.

Trial Locations (1)

48109

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

University of Michigan

OTHER

NCT07171489 - Efficacy of a Wearable Noninvasive Neuromodulation Device | Biotech Hunter | Biotech Hunter