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Deep Brain Stimulation for the Treatment of Traumatic Brain Injury

NCT02881151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-12-23

Study results available
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Summary

This study involves the treatment of cognitive impairment secondary to moderate to severe brain injury using central thalamic deep brain stimulation. Although all patients will receive stimulation continuously through a surgically implanted pacemaker-like device, half of the patients will have the device deactivated during a blinded assessment phase. The device will be reactivated following this assessment and patients will have the option to continue stimulation in an open-label continuation.

Conditions

  • TBI (Traumatic Brain Injury)

Interventions

DEVICE

Deep brain stimulation

Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device.

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • Jaimie M. Henderson

    lead OTHER

Principal Investigators

  • Jaimie M Henderson, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2021-10-13
Completion
2022-05-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02881151 on ClinicalTrials.gov