Recruiting

Upper Extremity Training

Sponsor:

Kessler Foundation

Code:

NCT04921592

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

upper extremity stimulation

Study Details

Brief summary:

This study is to understand how the combination of activity-based recovery training and targeted spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hand, arms, and core.

Conditions

Spinal Cord Injuries

Study ID

NCT04921592

Start date

Jun 14, 2021

Status verified date

May, 2025

Completion date

Nov 15, 2027

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age.
  • spinal cord injury for greater than or equal to 6 months.
  • spinal cord injury at a cervical neurologic level of injury.

Exclusion Criteria:

  • ventilator dependent.
  • history of fractures.
  • pressure sore or skin issues.
  • history of illicit drug abuse.
  • history of cardiac, respiratory, bladder, renal or other medical disorder unrelated to spinal cord injury.
  • bladder Botox injections less than 12 months prior.
  • muscle Botox injections less than 12 months prior.
  • colostomy bag or urostomy.
  • implanted pump (i.e., baclofen pump, pain pump, etc).
  • If I am female: I am pregnant at the time of enrollment or planning to become pregnant during the course of the study.
  • unable to wean from anti-spasticity medication.
  • contraindications to MRI imaging (pacemaker, metallic foreign body, aneurysm clip, etc.)

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: transcutaneous stimulation

1. transcutaneous stimulation 60 sessions
2. Transcutaneous stimulation 40sessions
3. Transcutaneous stimulation 20 sessions

Interventions

upper extremity stimulation

transcutaneous stimulation of the upper extremities

Primary outcome measure

  • Neuro Recovery Scale ( NRS). [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

LeighAnn Martinez, BA

973.324.3557lmartinez@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Research Manager

973-324-3557lmartinezn@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

May 6, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2025-05-06.