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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02881151
Recruitment Status : Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : June 15, 2021
Sponsor:
Collaborators:
Weill Medical College of Cornell University
University of Utah
Harvard Medical School
The Cleveland Clinic
Information provided by (Responsible Party):
Jaimie M. Henderson, Stanford University

Tracking Information
First Submitted Date  ICMJE August 22, 2016
First Posted Date  ICMJE August 26, 2016
Last Update Posted Date June 15, 2021
Actual Study Start Date  ICMJE April 20, 2017
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
Trail Making Test [ Time Frame: 1 year ]
The Trail Making Test is a measure of attention, speed and mental flexibility
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep Brain Stimulation for the Treatment of Traumatic Brain Injury
Official Title  ICMJE CT-DBS for Traumatic Brain Injury Using the Medtronic Activa PC+S System
Brief 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE TBI (Traumatic Brain Injury)
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 22, 2016)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • History of moderate to severe TBI based on worst GCS score within first 48 hours of injury (acceptable GCS range = 3-12)
  • Age 22-60
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02881151
Other Study ID Numbers  ICMJE 37280
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jaimie M. Henderson, Stanford University
Study Sponsor  ICMJE Jaimie M. Henderson
Collaborators  ICMJE
  • Weill Medical College of Cornell University
  • University of Utah
  • Harvard Medical School
  • The Cleveland Clinic
Investigators  ICMJE
Study Director: Jaimie M Henderson, MD Stanford University
PRS Account Stanford University
Verification Date June 2021

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