Task Practice and Spinal Cord Stimulation

Task Practice Combined With Transcutaneous Spinal Cord Stimulation to Reduce Muscle Co-contraction and Improve Motor Function in Chronic Spinal Cord Injury

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.

Study Overview

• Status: Recruiting
• Conditions: Spastic; Spinal Cord Injury Cervical
• Intervention / Treatment: Other: Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nilanjana Datta, MD; Phone Number: 3052436798; Email: nx693@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami - Christine E. Lynn Rehabilitation Center
      • Contact: Pedro M Pinheiro Saraiva, MSc; Phone Number: 3052436798; Email: pmp75@miami.edu
      • Principal Investigator: James D Guest, MD PhD
      • Contact: Nilanjana Datta, MD; Phone Number: 3052436798; Email: nxd693@miami.edu
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis
      • Contact: Nilanjana Datta, MD; Phone Number: 3052436978; Email: nxd693@miami.edu
      • Contact: Pedro M Pinheiro Saraiva, MSc; Phone Number: 3052436978; Email: pmp75@miami.edu
      • Principal Investigator: James D Guest, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 22-70 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.

Exclusion Criteria:

• 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.
• Has any active implanted medical device.
• Concurrent participation in another drug or device trial that may interfere with this study.
• In the opinion of the investigators, the study is not safe or appropriate for the participant.
• Persons who are unable to consent, pregnant women, and prisoners.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Task Practice with stimulation; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Spasticity as measured by Modified Ashworth Scale (MAS)	6 category ordinal scale (minimum value = 0 maximum value = 4) that measures spasticity where higher scores indicate greater spasticity.	baseline, up to 4 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: United States Department of Defense; ONWARD Medical, Inc.
• Investigators: Principal Investigator: James Guest, MD, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Transcutaneous; Transcutaneous Cervical Spinal Cord Stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 20230228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No