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Device

Deep brain stimulation for Traumatic Brain Injury

N/A
Waitlist Available
Research Sponsored by Jaimie M. Henderson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 24 months from date of onset
History of moderate to severe TBI based on worst GCS score within first 48 hours of injury (acceptable GCS range = 3-12)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-surgery baseline to treatment phase end (up to 197 days)
Awards & highlights

Study Summary

This trial is testing a pacemaker-like device that is implanted in the brain to help people with cognitive impairment from moderate to severe brain injuries. The device will be turned off for some patients during a part of the trial to see if it is effective.

Eligible Conditions
  • Traumatic Brain Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-surgery baseline to treatment phase end (up to 197 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-surgery baseline to treatment phase end (up to 197 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change in Trail Making Test Part B Time to Completion
Secondary outcome measures
Number of Participants With ≥1 Point Increase in Glasgow Outcome Scale - Extended Scale Score
Percent Change Traumatic Brain Injury Quality of Life - Attention/Concentration Short Form Scale Score
Percent Change in Patient Health Questionnaire - 9 Scale Score.
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Subjects will be treated with deep brain stimulation throughout the study, with the exception of a brief, 21 day blinded withdrawal phase that will be undertaken to assess for any possible therapeutic effect.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep brain stimulation
2010
Completed Phase 3
~380

Find a Location

Who is running the clinical trial?

Jaimie M. HendersonLead Sponsor
Weill Medical College of Cornell UniversityOTHER
1,052 Previous Clinical Trials
1,329,866 Total Patients Enrolled
University of UtahOTHER
1,088 Previous Clinical Trials
1,728,343 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Mar 2025