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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
Study Summary
This trial will test if a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) can help improve the functional outcome of people with chronic spinal cord injury (SCI) who are undergoing rehabilitation through robotics training.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Box and Blocks Test
Secondary outcome measures
Modified Ashworth Scale
Nine Hole Peg Test
Quadraplegia Index of Function- Short Form
+3 moreTrial 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.
Find a Location
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any risks associated with transcranial direct current stimulation?
"There is some evidence from other Phase 3 trials that transcranial direct current stimulation is effective and safe, so it received a score of 3."
Answered by AI
Could I qualify to participate in this experiment?
"This study is open to 13 individuals aged 18 to 99 that have quadriplegia. The main requirements for applicants are: having had the injury for longer than 6 months and motor impairment (this will be measured using the ASIA Impairment Scale)."
Answered by AI
Can patients join this particular clinical trial at this time?
"The clinicaltrials.gov website indicates that this study is not enrolling patients at the moment. 382 other studies are actively recruiting patients."
Answered by AI
Are individuals above the age of 20 welcome in this clinical trial?
"According to the rules that govern who can take part in this experiment, the youngest age an individual can be is 18 and the oldest is 99."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
California
How old are they?
18 - 65
What site did they apply to?
Burke Medical Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
i have some movement in my right arm but not in wrist and fingers so i hope this trial can help me.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
can it worsen my current condition?
PatientReceived no prior treatments
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