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tDCS for Spinal Cord Injury
Phase 3
Waitlist Available
Research Sponsored by Burke Medical Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately post-intervention, and 1 month follow up
Awards & highlights
Pivotal Trial
Summary
This trial uses brain stimulation and special exercises to help people with long-term spinal cord injuries improve their hand function. The brain stimulation makes the exercises more effective, potentially leading to better outcomes. Advances in technology have helped improve abilities in spinal cord injury survivors, and combining brain stimulation with exercise therapy has shown promise in improving hand function.
Eligible Conditions
- Spinal Cord Injury
- Quadriplegia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediately post-intervention, and 1 month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately post-intervention, and 1 month follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Box and Blocks Test
Secondary study objectives
Modified Ashworth Scale
Nine Hole Peg Test
Quadraplegia Index of Function- Short Form
+3 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
Participants in this arm will receive 20 minutes of 2 mA transcranial direct current stimulation over the primary motor cortex of the more affected arm prior to robotic training.
Group II: Sham tDCSPlacebo Group1 Intervention
Participants in this arm will receive 20 minutes of sham transcranial direct current stimulation over the primary motor cortex of the more affected arm prior to robotic training.
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Who is running the clinical trial?
Burke Medical Research InstituteLead Sponsor
23 Previous Clinical Trials
1,452 Total Patients Enrolled
New York State Spinal Cord Injury Research Board (SCIRB)UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a complete loss of movement and feeling in a specific part of your body.The injury is more than 6 months old.You have a history of seizures or have metal objects inside your head.You have had a head injury in the past or have problems with memory or thinking.You have paralysis in your arms and hands, but you are still able to pick up at least one block in a specific test.You have some movement ability, but not a complete range of motion.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Active tDCS
- Group 2: Sham tDCS
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT03555838 — Phase 3
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