Clinical trial NCT04921592: Upper Extremity Training for Chronic Cervical Spinal Cord Injury
Official title: Neuromodulation Training for Upper Extremity Recovery for Chronic Cervical Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Randomized into 1 of 3 groups
Primary purpose: OTHER

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.

Detailed description: 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. Activity-based recovery training aims to advance independence without the use of assistive devices. Spinal cord transcutaneous stimulation is an electrical stimulation that is provided on top of the skin over specific areas of the spinal cord to activate the circuitry for the activity that is being trained and reconnect with pathways between the brain and spinal cord.

i) Physical evaluation by the clinician or physician including the Classification of Spinal Cord Injury (ISNCSCI exam. ii) A series of tests to evaluate the trunk, arm function with and without using tests to evaluate muscle activation. iii) A series of questionnaires to evaluate function and quality of life iv) Two separate Magnetic Resonance Imaging (MRI) of spinal column (head to hip).

Randomized to one of three groups:

Group 1: will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 60 training sessions transcutaneous spinal stimulation.

Group 2: will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 40 training sessions of transcutaneous spinal stimulation. The group will then complete 20 sessions of rehabilitation therapy of the upper extremities and trunk (no stimulation).

Group 3: will be will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 20 training sessions of transcutaneous spinal stimulation. The group will then complete 40 sessions of rehabilitation therapy of the upper extremities and trunk (no stimulation).

Transcutaneous spinal stimulation will involve stimulating the spinal segments between C5/6 to lumber regions. Training time will be approximately 1 hour, 3-4 times per week.

Rehabilitation therapy will involve exercises concentrating on fingers, hand, arm and trunk function. A physical therapist will be at training and testing sessions.

Eligibility criteria: 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.)

Primary outcomes:
measure: Neuro Recovery Scale ( NRS).
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Gail F Forrest, PhD
role: PRINCIPAL_INVESTIGATOR
References: