Deep Brain Stimulation for the Treatment of Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT02881151|
Recruitment Status : Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : June 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|TBI (Traumatic Brain Injury)||Device: Deep brain stimulation||Not Applicable|
This preliminary safety study evaluates the use of the Medtronic Activa PC+S system and Medtronic Nexus-E system for central thalamic deep brain stimulation (CT-DBS) in the treatment of cognitive impairment secondary to traumatic brain injury (TBI). It involves a neurosurgical procedure in which electrodes are implanted in the brain, connected to an implanted pacemaker-like device in the chest. The proposed study, if successful, will provide supporting evidence for the development of a novel therapeutic approach utilizing CT-DBS to improve these enduring cognitive impairments arising in persons with multi-focal structural brain injuries. This research will address the critical gap of the lack of any available treatments. CT-DBS targets well-defined neuronal populations within the central thalamus that have known anatomical and physiological specializations, which not only provide a key role in arousal regulation during cognitively-mediated behaviors, but also exhibit a particular vulnerability to dysfunction in the setting of multi-focal, non-selective brain injuries.
Our proposed study aims to support development of CT-DBS as a novel therapeutic avenue for accessing cognitive reserve in patients with acquired brain injuries. In the proposed feasibility study of 6 subjects at a single investigational site, we will test the safety of CT-DBS in the severe traumatic brain injury (STBI) population with GOSE 6-7 level recovery and collect data to establish the translation of preclinical studies into human application of CT-DBS.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CT-DBS for Traumatic Brain Injury Using the Medtronic Activa PC+S System|
|Actual Study Start Date :||April 20, 2017|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||August 2022|
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.
Device: Deep brain stimulation
Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device.
- Trail Making Test [ Time Frame: 1 year ]The Trail Making Test is a measure of attention, speed and mental flexibility
- Measures of cognition [ Time Frame: 1 year ]Assessed using the Ruff 2 and 7
- Physical symptoms [ Time Frame: 1 year ]Assessed using the Rivermead Post-Concussion Symptom Questionnaire
- Psychological health [ Time Frame: 1 year ]Assessed using the Patient Health Questionnaire - 9, Columbia Suicide Severity Rating Scale
- Traumatic Brain Injury Quality of Life [ Time Frame: 1 year ]Assessed using the Traumatic Brain Injury Quality of Life scale
- Measure of global function [ Time Frame: 1 year ]Assessed using the Glasgow Outcome Scale - Extended
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881151
|United States, California|
|Stanford Health Care|
|Stanford, California, United States, 94305|
|Study Director:||Jaimie M Henderson, MD||Stanford University|