Task Practice and Spinal Cord Stimulation

NCT ID: NCT06494020

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2027-10-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Task Practice with stimulation

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

Group Type: EXPERIMENTAL

Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ONWARD Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

James D. Guest

Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Guest, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami - Christine E. Lynn Rehabilitation Center

Miami, Florida, United States

Site Status: RECRUITING

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

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nilanjana Datta, MD

Role: CONTACT

nx693@med.miami.edu

3052436798

Facility Contacts

Nilanjana Datta, MD

Role: primary

nxd693@miami.edu

3052436798

Pedro M Pinheiro Saraiva, MSc

Role: backup

pmp75@miami.edu

3052436798

Nilanjana Datta, MD

Role: primary

nxd693@miami.edu

3052436978

Pedro M Pinheiro Saraiva, MSc

Role: backup

pmp75@miami.edu

3052436978

Other Identifiers

20230228

Identifier Type: -

Identifier Source: org_study_id