Cervical tSCS for Traumatic Brain Injury

Overseen By Roberto M de Freitas, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roberto de Freitas

Must not be taking: Benzodiazepines

Disqualifiers: Severe cognitive impairments, PSH, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate (within the same experimental session)

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how non-invasive electrical stimulation of the spinal cord, known as transcutaneous electrical stimulation of the cervical spinal cord (tSCS), can improve arm and hand movement in individuals with motor impairments from a traumatic brain injury (TBI). Adhesive pads placed on the upper back deliver stimulation, aiming to enhance strength, movement control, and reduce muscle stiffness. This research could lead to new treatments that boost independence and quality of life for those affected by TBI. Individuals who experienced a TBI over a year ago and have difficulty moving their arms and hands might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform rehabilitation for TBI patients.

Will I have to stop taking my current medications?

If you are taking benzodiazepines for spasticity, you will need to stop taking them to participate in this trial. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the research team.

What prior data suggests that this method is safe for people with traumatic brain injury?

Research has shown that transcutaneous spinal cord stimulation (tSCS) is generally safe for people. One study used tSCS to improve arm and hand movement in individuals with spinal cord injuries. The results indicated it was well-tolerated, with no serious side effects.

Another study examined the effects of tSCS on heart health and found it did not cause any harmful changes to heart function. This suggests it is unlikely to pose a risk to heart health.

Overall, studies suggest that tSCS is safe and may help improve movement without causing significant health issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous electrical stimulation of the cervical spinal cord (tSCS) is unique because it offers a non-invasive approach to support recovery from traumatic brain injury (TBI). Unlike standard treatments for TBI, which often involve medications or surgery to manage symptoms and complications, tSCS stimulates the nervous system directly through the skin to potentially enhance neural recovery and function. Researchers are excited about this technique because it targets the spinal cord to improve communication between the brain and body, which could lead to better outcomes without the need for invasive procedures.

What evidence suggests that transcutaneous spinal cord stimulation (tSCS) is effective for improving arm and hand movement in people with traumatic brain injury?

Studies have shown that transcutaneous spinal cord stimulation (tSCS) can aid recovery from spinal cord injuries. Research indicates that tSCS can enhance grip and arm and hand function. This electrical stimulation helps the brain rewire itself, potentially improving long-term recovery. tSCS is non-invasive, using pads on the skin to send electrical signals, making it safer than surgical procedures. In this trial, participants will receive tSCS to explore its effects on traumatic brain injury (TBI). Although data collection on its effects on TBI is ongoing, the positive results observed in spinal cord injuries offer hope for improving movement and strength in individuals with TBI. ^{1 3 6 7 8}

Who Is on the Research Team?

Roberto M de Freitas, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults aged 21-70 with motor impairments from a traumatic brain injury (TBI) at least one year old, and healthy controls with full upper limb motion. Excluded are those with severe cognitive issues, certain medications like benzodiazepines, implanted devices, serious diseases, uncontrolled epilepsy, or women who are pregnant/breastfeeding.

Inclusion Criteria

I can move my arms fully without any restrictions.

I had a traumatic brain injury over a year ago affecting my arm and hand movements.

I am between 21 and 70 years old.

Exclusion Criteria

I have a TBI and scored less than 12 on the consent form evaluation.

I am taking benzodiazepine for muscle stiffness due to a brain injury.

I have severe cognitive or behavioral issues due to a brain injury that may affect my study participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous spinal cord stimulation (tSCS) to assess immediate effects on upper limb motor functions

Immediate (within the same experimental session)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous electrical stimulation of the cervical spinal cord (tSCS)

Trial Overview The study tests non-invasive electrical stimulation of the spinal cord (tSCS) to improve arm and hand movement in TBI patients. It involves adhesive pads on the skin over the upper back and measures changes in strength, control and muscle spasticity.

How Is the Trial Designed?

Group I: Transcutaneous electrical stimulation of the cervical spinal cord (tSCS) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Roberto de Freitas

Lead Sponsor

Chuck Noll Foundation

Collaborator

Trials

1

Recruited

50+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07147816

NCT07147816 | Cervical Transcutaneous SCS for TBI The goal of this study is to test the effects of non-invasive electrical stimulation of the spinal cord (called transcutaneous spinal cord stimulation, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6986544/

Transcutaneous Electrical Spinal Stimulation Promotes Long ... These data suggest that noninvasive electrical stimulation of spinal networks can promote neuroplasticity and long-term recovery following SCI.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... This study showed that tSCS combined with ABT is safe, feasible, and effective in adults with chronic SCI ranging from the cervical to thoracic level when ...

4. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ... Improvements in upper extremity (UE) grip strength (11, 12) as well as UE function (11) have been reported in response to cervical TSCS, even in ...

5. trialx.com trialx.com/clinical-trials/listings/308632/cervical-transcutaneous-scs-for-tbi/

Cervical Transcutaneous SCS for TBI The main goal of this study is to assess the immediate effects of cervical transcutaneous spinal cord stimulation (tSCS) on arm and hand motor functions after ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014404/

Cardiovascular safety of transcutaneous spinal cord ... The Up-LIFT trial evaluated the safety and effectiveness of programmed non-invasive spinal cord stimulation (ARCEX Therapy, ONWARD Medical, Inc.

7. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(23)00648-7/fulltext

Safety and Feasibility of Cervical and Thoracic ... To our knowledge, there is no study that has reported safety and feasibility of cervical scTS applied to improve UE motor function in children ...

8. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.