Upper Extremity Training for Chronic Cervical Spinal Cord Injury

NCT04921592 | Recruiting

• 1 other identifier: R-1153-21
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Neuro Recovery Scale ( NRS).

  Measure of the degree a person who has sustained a spinal cord injury (SCI) has recovered the ability to perform functional tasks relative to how the individual performed these tasks prior to injury. The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This type of scale can be administered verbally.

  6 months

Study Arms (1)

transcutaneous stimulation

EXPERIMENTAL

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

Other: upper extremity stimulation

Interventions

upper extremity stimulation OTHER

transcutaneous stimulation of the upper extremities

Also known as: Activity-Based Recovery Therapy (ABRT)

transcutaneous stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Gail F Forrest, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LeighAnn Martinez, BA

CONTACT

973.324.3557; lmartinez@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Spinal Stimulation

Model Details: Randomized into 1 of 3 groups

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: June 10, 2021
• Study Start: June 14, 2021
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)