Task Practice and Spinal Cord Stimulation

NCT06494020 | Recruiting

• 1 other identifier: 20230228
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to understand the effects of combined task practice with transcutaneous cervical spinal cord stimulation. The study will explore the effect of higher stimulation frequencies on spasticity. Transcutaneous stimulation has been shown to improve motor function in some individuals with chronic spinal cord injury. The study intends to explore scientifically the association between higher stimulation frequencies and spasticity/hypertonicity.

Conditions

Spinal Cord Injury Cervical; Spastic

Keywords

Transcutaneous; Transcutaneous Cervical Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in motor performance as measured by The Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) test

  GRASSP is a multimodal test that measures sensorimotor and prehension function in three domains that are important for the description of arm and hand functions, namely strength, sensation and prehension strength. It is an ordinal scale (minimum value = 0, maximum value = 100) with higher scores indicating better performance. There is a sensation category ordinal scale (minimum value = 0 maximum value = 24) that measures sensation where higher scores indicate greater sensation. The Prehension performance category has an ordinal scale (minimum value = 0 maximum value = 40) that measures prehension where higher scores indicate greater ability.

  baseline, up to 4 months

Secondary Outcomes (1)

• Change in Spasticity as measured by Modified Ashworth Scale (MAS)

  baseline, up to 4 months

Study Arms (1)

Task Practice with stimulation

EXPERIMENTAL

Participants in this group will receive combined Transcutaneous cervical spinal cord stimulation with task practice for up to 2 months.

Other: Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)

Interventions

Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS) OTHER

Hand rehabilitative tasks ( for gross hand movement, grasp and pinch tasks) will be done by participants during which time the participant will receive TcSCS. This will be done three times a week for 60 minutes.

Task Practice with stimulation

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Non-progressive cervical spinal cord injury
• Minimum 12 months year post-injury.
• American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D.
• Able to take part in upper extremity therapy procedures.
• GRASSP-Prehension score ≥10.
• MAS Score ≥3 but \<6 in at least one arm.
• Can commit to the time required for the study.
• Stable medication profile for at least 4 weeks prior to enrollment.
• Able to reduce Baclofen dose to 30 mg or less daily.
• Capable of providing informed consent.

You may not qualify if:

• Has any unstable or significant medical condition that is likely to interfere with study procedures like severe neuropathic pain, depression, mood disorders, or other cognitive disorders.
• Has uncontrolled cardiopulmonary disease or cardiac symptoms.
• Requires ventilator support.
• Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled.
• Has an autoimmune etiology of spinal cord dysfunction/injury
• Previously diagnosed as having transverse myelitis
• History of additional neurologic diseases such as stroke, multiple sclerosis, traumatic brain injury, epilepsy or history of seizures.
• Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
• Uncontrolled spasms, which have been unstable over the past three months prior to enrollment and are not expected to change.
• Received Botulinum toxin injections in their upper extremity, neck, or hand within six months prior to enrollment.
• Has painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection at the time of enrollment.
• Breakdown in skin area that will come into contact with electrodes.
• Presence of syringomyelia as determined by an MRI.
• Currently undergoing treatment for cancer or has been in remission for less than 2 years.
• Received stem cell treatment within the past two years prior to enrollment.

Sponsors & Collaborators

• University of Miami: lead
• ONWARD Medical, Inc.: collaborator
• United States Department of Defense: collaborator

Study Sites (2)

University of Miami - Christine E. Lynn Rehabilitation Center

Miami, Florida, 33136, United States

RECRUITING

University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Guest, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nilanjana Datta, MD

CONTACT

3052436798; nx693@med.miami.edu

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: Professor of Clinical

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)