CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
Deep brain stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02881151
NCT02881151N/ACompleted
CompareCT.gov

CT-DBS for Traumatic Brain Injury Using the Medtronic Activa PC+S System

Jaimie M. Henderson·interventional·Posted Aug 26, 2016·Updated Dec 23, 2022

In Brief

A clinical study evaluating Deep brain stimulation for TBI (Traumatic Brain Injury). Completed, enrolled 6 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTBI (Traumatic Brain Injury)
CountriesUnited States
CollaboratorsWeill Medical College of Cornell University, University of Utah, Harvard Medical School (HMS and HSDM), The Cleveland Clinic

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 26, 2016
Enrollment StartApr 20, 2017
Primary CompletionOct 13, 2021
Study CompletionMay 4, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.8 years ago

Interventions

Deep brain stimulationdevice

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