Deep Brain Stimulation for the Treatment of Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02881151
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : August 14, 2018
Information provided by (Responsible Party):
Jaimie M. Henderson, Stanford University

August 22, 2016
August 26, 2016
August 14, 2018
April 20, 2017
November 30, 2019   (Final data collection date for primary outcome measure)
Trail Making Test [ Time Frame: 1 year ]
The Trail Making Test is a measure of attention, speed and mental flexibility
Same as current
Complete list of historical versions of study NCT02881151 on Archive Site
  • 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
  • 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
Same as current
Not Provided
Not Provided
Deep Brain Stimulation for the Treatment of Traumatic Brain Injury
CT-DBS for Traumatic Brain Injury Using the Medtronic Activa PC+S System
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.

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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
TBI (Traumatic Brain Injury)
Device: Deep brain stimulation
Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device.
Other Names:
  • DBS
  • CT-DBS
  • Central Thalamic DBS
Experimental: Treatment
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.
Intervention: Device: Deep brain stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2020
November 30, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of moderate to severe TBI based on worst GCS score within first 48 hours of injury (acceptable GCS range = 3-9)
  • Age 22-55
  • At least 24 months from date of onset
  • Fluent in English and able to independently provide consent
  • Rating of upper moderate disability to lower good recovery on the Glasgow Outcome Scale-Extended (GOSE) at time of enrollment (acceptable GOSE range 5-7)
  • Performance ≥ 2 SD's below the demographically-corrected mean on at least one attention, memory or executive function measure at baseline
  • Failure to return to pre-injury level of vocational or educational function
  • Either receiving no CNS stimulants or other medications known to affect cognitive function, or on stable doses of these medications for the last three months

Exclusion Criteria:

  • History of major developmental, neurologic, psychiatric or substance use disorder with evidence of disability prior to onset of TBI
  • Major medical co-morbidities including: end stage renal failure, severe heart failure, coagulopathy, severe respiratory problems, severe liver failure, uncontrolled hypertension or other significant medical co morbidities
  • Have had a documented seizure within 3 months of study screening (subjects may re-screen if seizure free after initial screen failure)
  • Malignancy with < 5 years life expectancy
  • Untreated / uncontrolled (severe at the time of enrollment) depression or other psychiatric disorder
  • Women of childbearing age who do not regularly use an accepted contraceptive method
  • Inability to stop anticoagulation therapy or platelet anti-aggregation therapy before, during and after surgery
  • Previous DBS or other brain implants
  • Previous ablative intracranial surgery
  • Implantable hardware not compatible with MRI
  • Condition requiring diathermy after DBS implantation
  • Hardware, lesions or other factors limiting placement of electrodes in optimal target location in the judgment of the operating surgeon
  • Concurrent enrollment in any other clinical trial
  • Any condition or finding that, in the judgment of the PI, significantly increases risk or significantly reduces the likelihood of benefit from DBS
Sexes Eligible for Study: All
22 Years to 60 Years   (Adult)
Contact: Hong Ye, MS 650-206-0536
United States
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Plan to Share IPD: No
Jaimie M. Henderson, Stanford University
Jaimie M. Henderson
Not Provided
Study Director: Jaimie M Henderson, MD Stanford University
Stanford University
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP