Deep Brain Stimulation for the Treatment of Traumatic Brain Injury

NCT02881151 | Completed Results DMC FDA Device

• 1 other identifier: 37280
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

Deep brain stimulation; DBS; Central thalamus; TBI; Traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Percent Change in Trail Making Test Part B Time to Completion

  The Trail Making Test is a measure of attention, speed and mental flexibility. It also tests spatial organization, visual pursuits, recall, and recognition. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility. Both sections are timed and the score represents the amount of time required to complete the task. Lower scores (shorter times) correspond to a better outcome.

  Pre-surgery baseline to treatment phase end (up to 197 days)

Secondary Outcomes (11)

• Percent Change in Trail Making Test Part A Time to Completion

  Pre-surgery baseline to treatment phase end (up to 197 days)

• Percent Change in Traumatic Brain Injury Quality of Life - Executive Function Short Form (TBI-QOL) Scale Score

  Pre-surgery baseline to treatment phase end (up to 197 days)

• Percent Change Traumatic Brain Injury Quality of Life - Attention/Concentration Short Form Scale Score

  Pre-surgery baseline to treatment phase end (up to 197 days)

• Percent Change in Traumatic Brain Injury Quality of Life - Fatigue Short Form Scale Score

  Pre-surgery baseline to treatment phase end (up to 197 days)

• Percent Change in Rivermead Post-Concussion Symptom Questionnaire Scale Score

  Pre-surgery baseline to treatment phase end (up to 197 days)

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Deep brain stimulation DEVICE

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

Also known as: DBS, CT-DBS, Central Thalamic DBS

Treatment

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaimie M. Henderson: lead
• Weill Medical College of Cornell University: collaborator
• University of Utah: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

Related Publications (2)

• Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.

  PMID: 9726257 BACKGROUND

• Schiff ND, Giacino JT, Butson CR, Choi EY, Baker JL, O'Sullivan KP, Janson AP, Bergin M, Bronte-Stewart HM, Chua J, DeGeorge L, Dikmen S, Fogarty A, Gerber LM, Krel M, Maldonado J, Radovan M, Shah SA, Su J, Temkin N, Tourdias T, Victor JD, Waters A, Kolakowsky-Hayner SA, Fins JJ, Machado AG, Rutt BK, Henderson JM. Thalamic deep brain stimulation in traumatic brain injury: a phase 1, randomized feasibility study. Nat Med. 2023 Dec;29(12):3162-3174. doi: 10.1038/s41591-023-02638-4. Epub 2023 Dec 4.

  PMID: 38049620 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Jaimie Henderson
• Organization: Stanford University School of Medicine

henderj@stanford.edu

+1 (650) 723-5574

Study Officials

• Jaimie M Henderson, MD

  Stanford University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: John and Jene Blume - Robert and Ruth Halperin Professor

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 26, 2016
• Study Start: April 20, 2017
• Primary Completion: October 13, 2021
• Study Completion: May 4, 2022
• Last Updated: December 23, 2022
• Results First Posted: December 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)