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About this sponsor

Jaimie M Henderson


You will receive

Study related treatment at no cost


To qualify, you must be

Male or Female

22 - 55

Years Old


This is where the study procedures will take place

Travel expenses may be reimbursed


Showing 1 of 1 available location(s)
Stanford Health Care Claim this site

Recruiting United States, Stanford California


Treated Condition

About This Condition


Study Details

Click each topic to learn more


Who can participate?

Ideal candidates should meet the following criteria

  • Performance ≥ 2 SD's below the demographically-corrected mean on at least one attention, memory or executive function measure at baseline
  • Rating of upper moderate disability to lower good recovery on the Glasgow Outcome Scale-Extended (GOSE) at time of enrollment (acceptable GOSE range 6-7)
  • Fluent in English and able to independently provide consent
  • At least 24 months from date of onset
  • Age 22-55
  • History of moderate to severe TBI based on worst GCS score within first 48 hours of injury (acceptable GCS range = 3-9)
  • 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
  • Failure to return to pre-injury level of vocational or educational function

Reasons you may not be a good fit

  • 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
  • Hardware, lesions or other factors limiting placement of electrodes in optimal target location in the judgment of the operating surgeon
  • Condition requiring diathermy after DBS implantation
  • Implantable hardware not compatible with MRI
  • Previous ablative intracranial surgery
  • Malignancy with < 5 years life expectancy
  • Inability to stop anticoagulation therapy or platelet anti-aggregation therapy before, during and after surgery
  • Previous DBS or other brain implants
  • Women of childbearing age who do not regularly use an accepted contraceptive method
  • Untreated / uncontrolled (severe at the time of enrollment) depression or other psychiatric disorder
  • Have had a documented seizure within 3 months of study screening (subjects may re-screen if seizure free after initial screen failure)
  • 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
  • History of major developmental, neurologic, psychiatric or substance use disorder with evidence of disability prior to onset of TBI


About This Study

Name

Deep brain stimulation for the treatment of traumatic brain injury

Status

Recruiting

ID

NCT02881151

Phase

NA

Type

Interventional

Summary

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

Purpose

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 an 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.

Details

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). 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 Interventions
Device(s)

Deep brain stimulation

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


What will be monitored/measured (Outcomes)

Trail Making Test

1 year

The Trail Making Test is a measure of attention, speed and mental flexibility


Measures of cognition

1 year

Assessed using the Ruff 2 and 7


Physical symptoms

1 year

Assessed using the Rivermead Post-Concussion Symptom Questionnaire


Psychological health

1 year

Assessed using the Patient Health Questionnaire - 9, Columbia Suicide Severity Rating Scale


Quality of Life

1 year

Assessed using the Traumatic Brain Injury Quality of Life scale


Measure of global function

1 year

Assessed using the Glasgow Outcome Scale - Extended


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