Paired Spinal Cord and Peripheral Nerve Stimulation to Recover Hand Function in SCI

NCT06698224 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 1176828
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. This project aims to test the effects of pairing spinal cord and nerve stimulation combined with physical therapy training in recovering arms and hand function. The long-term goal is to provide better therapies that will improve the ability of individuals with spinal cord injuries to use their arms and hands to perform everyday tasks, similar to injury before.

Conditions

Spinal Cord Injury; Spinal Cord Disease; Spinal Cord Injuries (SCI)

Keywords

Spinal cord injury; Hand function; Spinal cord stimulation; Paired stimulation; Physical therapy

Outcome Measures

Primary Outcomes (6)

• GRASSP

  Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is a 3-part assessment designed to measure participant's hand and arm function. The test specifically measures strength, sensation, and prehension. During strength testing, selected upper extremity muscles are assessed for the grade of muscle contraction or power of the muscle. During sensation testing, specific zones on the palmar and dorsal aspects of the hand are tested with Semmes Weinstein Monofilaments (SWM) with varying weights. Prehension is assessed both qualitatively and quantitatively. During the qualitative section, no specific position is required, except that the hand should be positioned appropriately for movement with assistance from the examiner, if necessary. During quantitative section, participant is asked to perform six tasks and performance is graded.

  From enrollment to the end of treatment at 4 weeks

• NRS

  Neuromuscular Recovery Scale Assessment (NRS) assesses the level of muscle activation and amount of external assistance required to perform motor tasks involving hand, arm, and trunk. The research participant will be asked to perform motor tasks as independently as possible. Research staff will score each of these tasks based on the algorithm. NRS consists of six sub-items focusing on UE function, including overhead press, shoulder flexion, grasp, door pull, open with key, and can open and manipulation. Items are scored from phase 1 to phase 4, the higher the phase, the better is the functional performance

  From enrollment to the end of treatment at 4 weeks

• Voluntary hand opening and closing kinematics

  Three-dimensional kinematic data will be collected using a motion capture system. Reflective markers will be placed on the participant's forearm, hand, and fingers to track wrist and finger movements during a maximum hand opening and closing task. Surface electrodes will be applied on the participant's skin to acquire EMG data.

  From enrollment to the end of treatment at 4 weeks

• Maximal voluntary grip strength

  For maximal voluntary grip strength, participants will be instructed to apply as much force as possible while trying to grasp or making a fist around the grip handle during a 3 second audio cue. Each MVC attempt will be followed by a rest period of 20 seconds of no activity. A total of 5 grip strength attempts will be collected.

  From enrollment to the end of treatment at 4 weeks

• Transcranial magnetic stimulation motor evoked potential (MEP)

  To obtain MEP, transcortical magnetic stimulation (TMS) will be delivered through a figure-of-eight coil using a monophasic current waveform to the optimal scalp position along the arm and hand representation of the primary motor cortex eliciting largest MEP (MEPmax) from targeted arm and hand muscles. Electromyographic (EMG) sensors will be applied on the participant's skin to acquire muscle data.

  From enrollment to the end of treatment at 4 weeks

• F-wave

  120% of the maximum stimulation intensity causing plateauing of the M-wave will be used to elicit F-wave. Evoked responses will be recorded using low-noise, pre-amplified surface EMG electrodes placed on the arm and hand muscles to record signals.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (5)

• Functional Neurophysiological assessment (FNPA)

  From enrollment to the end of treatment at 4 weeks

• Multisegmental Motor Response (MMR)

  From enrollment to the end of treatment at 4 weeks

• Capabilities of Upper Extremity Questionnaire (CUE-Q)

  From enrollment to the end of treatment at 4 weeks

• Spinal Cord Injury-Quality of Life (SCI-QOL) Questionnaire

  From enrollment to the end of treatment at 4 weeks

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) - ASIA Impairment Scale (AIS)

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

scTS

ACTIVE COMPARATOR

This arm will receive 20 sessions of spinal cord transcutaneous stimulation (scTS) combined with physical therapy.

Device: Spinal cord transcutaneous stimulation

scTS+PNS

EXPERIMENTAL

This arm will receive 20 sessions of paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS) followed by scTS combined with physical therapy.

Device: Paired spinal cord and peripheral nerve stimulation

Interventions

Spinal cord transcutaneous stimulation DEVICE

Physical therapy combined with spinal cord transcutaneous stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord stimulation is a non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.

scTS

Paired spinal cord and peripheral nerve stimulation DEVICE

Physical therapy combined with paired spinal cord-peripheral nerve stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord and peripheral nerve stimulation are both non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.

Also known as: Spinal cord transcutaneous stimulation, Peripheral nerve stimulation

scTS+PNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Non-progressive cervical SCI
• Greater than or equal to 6-months post spinal cord injury
• Stable medical condition
• Viable median and ulnar nerve as evident from MMR and M-Wave recordings
• Wrist extensor and finger flexors score between 1-3 for both upper extremity for ISNCSCI motor assessment.

You may not qualify if:

• Ventilator Dependent
• Untreated fracture or pressure ulcer
• Untreated psychiatric disorder or ongoing drug abuse
• Cardiac, respiratory, bladder, renal, or other untreated medical disorder unrelated to SCI
• Skeletal muscle Botox injections less than 6 months prior
• Previous tendon transfer of the arm or arms
• Any implanted pump (i.e., baclofen pump, pain pump, etc.) prior to randomization
• Pregnant at the time of enrollment or planning to become pregnant during the course of the study
• Unable or unwilling to wean from anti-spasticity medications
• History of seizure or epilepsy
• Metal in Head
• Cochlear implant
• Implanted brain stimulators
• Aneurysm clips
• Increased intracranial pressure (which lowers seizure threshold)

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Publications (4)

• Sharma P, Naglah A, Aslan S, Khalifa F, El-Baz A, Harkema S, D'Amico J. Preservation of functional descending input to paralyzed upper extremity muscles in motor complete cervical spinal cord injury. Clin Neurophysiol. 2023 Jun;150:56-68. doi: 10.1016/j.clinph.2023.03.003. Epub 2023 Mar 17.

  PMID: 37004296 BACKGROUND

• Singh G, Sharma P, Forrest G, Harkema S, Behrman A, Gerasimenko Y. Spinal Cord Transcutaneous Stimulation in Cervical Spinal Cord Injury: A Review Examining Upper Extremity Neuromotor Control, Recovery Mechanisms, and Future Directions. J Neurotrauma. 2024 Sep;41(17-18):2056-2074. doi: 10.1089/neu.2023.0438. Epub 2024 Jul 12.

  PMID: 38874496 BACKGROUND

• Sharma P, Panta T, Ugiliweneza B, Bert RJ, Gerasimenko Y, Forrest G, Harkema S. Multi-Site Spinal Cord Transcutaneous Stimulation Facilitates Upper Limb Sensory and Motor Recovery in Severe Cervical Spinal Cord Injury: A Case Study. J Clin Med. 2023 Jun 30;12(13):4416. doi: 10.3390/jcm12134416.

  PMID: 37445450 BACKGROUND

• Zhang F, Momeni K, Ramanujam A, Ravi M, Carnahan J, Kirshblum S, Forrest GF. Cervical Spinal Cord Transcutaneous Stimulation Improves Upper Extremity and Hand Function in People With Complete Tetraplegia: A Case Study. IEEE Trans Neural Syst Rehabil Eng. 2020 Dec;28(12):3167-3174. doi: 10.1109/TNSRE.2020.3048592. Epub 2021 Jan 28.

  PMID: 33382659 BACKGROUND

Related Links

• Tim and Caroline Reynolds Center for Spinal Stimulation at Kessler Foundation

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Gail Forrest, Ph.D.

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LeighAnn Martinez

CONTACT

973-324-3557; lmartinez@kesslerfoundation.org

Pawan Sharma, Ph.D.

CONTACT

973-324-3557; psharma@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 20, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)