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Neurostimulation Device

Spinal Cord Stimulation for Quadriplegia

N/A
Recruiting
Led By Monica A Perez, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female Veterans between 18-70 years with chronic SCI (1 year of injury)
Chronic SCI (1 year of injury)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion(average of 5 weeks) and during 6-month follow-up
Awards & highlights

Study Summary

This trial will examine the effects of TESS on upper-limb muscles after cervical SCI, with the goal of increasing reaching and grasping potential.

Who is the study for?
This trial is for male and female Veterans aged 18-70 with chronic spinal cord injury (SCI) at least one year old, specifically those who can grip with one hand and have a cervical injury above C8. Participants must not be pregnant, have debilitating diseases or major depression/psychosis, head injuries, uncontrolled medical issues, metal in the skull, history of seizures or drugs that lower seizure threshold.Check my eligibility
What is being tested?
The study tests TESS (transcutaneous electrical spinal stimulation), combined with motor training tasks to improve upper-limb function after SCI. It compares the effects of actual TESS versus sham (fake) treatment on muscle behavior and recovery potential in reaching/grasping movements.See study design
What are the potential side effects?
While specific side effects are not listed here, similar studies suggest possible skin irritation from electrodes, discomfort from electrical stimulation or muscle fatigue during training sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a Veteran aged 18-70 with a spinal cord injury for over a year.
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I have had a spinal cord injury for over a year.
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I can visibly squeeze my hand into a fist.
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I can grasp objects with at least a minimal grip.
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I have normal or altered sensation in my upper limbs.
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My MRI shows damage in my neck at C8 or above.
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I am a Veteran aged between 18 and 70.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion(average of 5 weeks) and during 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion(average of 5 weeks) and during 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in GRASSP Test
Changes in amplitude of Motor evoked potential size
Changes in amplitude of cervicomedullary motor evoked potential size

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Active TESS + TrainingActive Control3 Interventions
Develop methodologies to promote recovery of reaching and grasping movements. To accomplish this goal, the investigators will combine TESS applied in a closed-loop manner with massed practice upper-limb training. Participants will be assigned to one of three groups in a randomized order for a controlled design: [1) Closed-loop TESS applied during grasping + training, 2) Closed-loop TESS applied during reaching + training, and 3) Closed-loop TESS applied during grasping & reaching + training.] TESS for 20-min will be followed by 60 min of massed practice exercise training (total=20 sessions).
Group II: Active TESS Group 1Active Control3 Interventions
Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, active transcutaneous electrical spinal stimulation (TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.
Group III: Sham TESS Group 1Placebo Group3 Interventions
Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, sham transcutaneous electrical spinal stimulation (sham-TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,343 Total Patients Enrolled
Monica A Perez, PhDPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
3 Previous Clinical Trials
277 Total Patients Enrolled

Media Library

TESS (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05157282 — N/A
Spinal Cord Injury Research Study Groups: Active TESS + Training, Sham TESS Group 1, Active TESS Group 1
Spinal Cord Injury Clinical Trial 2023: TESS Highlights & Side Effects. Trial Name: NCT05157282 — N/A
TESS (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05157282 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation accept participants over the age of seventy?

"This clinical trial requires applicants to be within the age range of 18-70 years old. Separately, there are 37 trials for patients below the legal age and 316 for those who are older than 65."

Answered by AI

Am I able to participate in this research endeavor?

"This clinical trial is admitting 86 individuals aged 18-70 who have sustained a spinal cord injury. The participants must be able to generate visible power grip with one hand and score at least two on the GRASSP Prehension Ability Test in order to guarantee that their impairment won't impede training or testing procedures. Moreover, appropriate candidates should be right-handed, possess intact or impaired but not absent innervations of C6, C7 and C8 dermatomes as observed through light touch/pin prick tests according to ISNCSCI standards (Bunday & Perez 2012; Bunday et al., 2018; Benavides et"

Answered by AI

What is the upper bound of participants involved in this research project?

"Affirmative. Based on the information provided by clinicaltrials.gov, this trial is actively recruiting participants as of now. It was initially posted in January 3rd 2022 and its most recent edit was done on February 3rd 2022; 86 individuals are needed to participate at two sites."

Answered by AI

Does this investigation currently require more participants?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently recruiting subjects - it was first posted on March 1st 2022 and the most recent update happened a month later. A total of 86 patients are needed from two separate sites."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Shirley Ryan AbilityLab
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia
2023. "Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05157282.
~32 spots leftby Jan 2025
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