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Transcutaneous Spinal Cord Stimulation for Chronic Spinal Cord Injury

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Study Aim

This study aims to evaluate the effect of transcutaneous spinal cord stimulation on improving motor performance in individuals with chronic spinal cord injury.

What is being tested

Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)

Other
Who is being recruted

Muscle Hypertonia+6

+ Muscle Spasticity

+ Muscular Diseases

From 22 to 70 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: September 2024
See protocol details

Summary

Principal SponsorUniversity of Miami
Study ContactNilanjana Datta, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on individuals with chronic spinal cord injuries and aims to understand how a combination of task practice and a technique called transcutaneous cervical spinal cord stimulation can help improve motor functions. This type of stimulation involves using electrical currents applied through the skin on the neck area. The research is particularly interested in seeing how different levels of stimulation might affect muscle tightness, known as spasticity, which is a common problem for those with spinal cord injuries. Understanding these effects could lead to better management and improvement of motor functions for people living with these injuries. Participants will engage in specific tasks that are intended to practice and improve their motor skills, while at the same time receiving the spinal cord stimulation. The stimulation is non-invasive, as it is applied through the skin, and will be administered at varying frequencies to assess its impact on muscle co-contraction and spasticity. The study will measure changes in muscle tightness and overall motor function to evaluate the effectiveness of this combined approach. Through this, the research aims to find the most beneficial stimulation settings to help reduce muscle stiffness and enhance movement abilities.

Official TitleTask Practice Combined With Transcutaneous Spinal Cord Stimulation to Reduce Muscle Co-contraction and Improve Motor Function in Chronic Spinal Cord Injury
NCT06494020
Principal SponsorUniversity of Miami
Study ContactNilanjana Datta, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 22 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Muscle HypertoniaMuscle SpasticityMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeuromuscular Manifestations

Criteria

11 inclusion criteria required to participate
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.

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19 exclusion criteria prevent from participating
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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

University of Miami - Christine E. Lynn Rehabilitation Center

Miami, United StatesOpen University of Miami - Christine E. Lynn Rehabilitation Center in Google Maps
Recruiting

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

Miami, United States
Recruiting
2 Study Centers