Traumatic Brain Injury Peripheral Nerve Study (TBI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01588691
First received: February 15, 2012
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

Peripheral nerve stimulation for the treatment of sequelae due to traumatic brain injury. This study will specifically examine patients with mild traumatic brain injury (TBI) who have persistent cognitive impairments lasting one year or longer. Neuropsychological testing will occur to confirm the diagnosis.


Condition Intervention Phase
Traumatic Brain Injury
Device: Eon-mini IPG (implantable pulse generator)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Feasibility Study to Examine the Efficacy of C2-C3 Dermatomal Peripheral Nerve Stimulation in Cognitive Improvements Following Persistent Impairment After Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Reduction in persistent cognitive impairments [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: December 2011
Estimated Study Completion Date: September 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low frequency
Programming parameters with the Eon Mini will be set at a low frequency. Subjects will remain in this group for 3 weeks. If subject cannot tolerate this frequency, he/she will meet with the clinical designee for reprogramming.
Device: Eon-mini IPG (implantable pulse generator)
programming parameters set at low frequency. Patients will receive this therapy dose for 3 weeks.
Other Name: Eon-mini IPG (implantable pulse generator)
Active Comparator: High frequency
Programming parameters with the Eon Mini will be set at a low frequency. Subjects will remain in this group for 3 weeks. If subject cannot tolerate this frequency, he/she will meet with the clinical designee for reprogramming.
Device: Eon-mini IPG (implantable pulse generator)
programming parameters set at high frequency. Patients will receive this therapy dose for 3 weeks.
Other Name: Eon-mini IPG (implantable pulse generator)
Placebo Comparator: No stimulation
Programming parameters will be set to the lowest possible level and minimal power will be generated. Subjects will remain in this group for 3 weeks. If subject cannot tolerate this frequency, he/she will meet with the clinical designee for reprogramming.
Device: Eon-mini IPG (implantable pulse generator)
programming parameters set at lowest settings to deliver minimal power. Patients will receive this therapy dose for 3 weeks.
Other Name: Eon-mini IPG (implantable pulse generator)

Detailed Description:

The subject will complete participation in three groups evaluating different programming parameters. After surgery, each subject will be randomized to Group A or Group B. Group C will be completed in the middle followed by the alternate A/B Group. Crossover will occur at 3 week intervals until subjects complete all three groups. During this period, all subjects will receive a subject programmer that will only enable them to activate the "on and off" positions and adjust amplitude within the prescribed range.

After subjects have completed the three pre-defined groups they will select the most effective and comfortable setting continuation of the study. The pulse width and frequency parameters will be set to the optimal settings identified by the subject. Amplitude will be set at a level that produces comfortable paresthesia for the subject.

Subjects will return to the clinic for programming changes post system internalization at 3 weeks, 6 weeks, and 9 weeks. Subjects will receive a PET scan at the 3 and 9 week visit. Additional follow-up evaluations will occur at 12 weeks, 18 weeks, and 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects able to provide informed consent to participate in the study;
  2. Subjects between the ages of 18 and 65;
  3. Subjects with clear evidence and/or documentation of mild traumatic brain injury as defined by the American Congress on Rehabilitation Medicine (1993):

    • Closed head injury/trauma
    • Score of 13-15 on the Glasgow Coma Scale
    • Documented/witnessed loss of consciousness < 30 minutes post injury
    • Post traumatic amnesia less than 24 hours post injury.
  4. Subjects 12 month post-injury with DSM IV diagnosis of Postconcussive Disorder Research Criteria (see Appendix A for detailed definition):

    • Evidence from neuropsychological testing of difficulty in attention or memory
    • Complaints, at baseline, of three or more postconcussive symptoms that have been present at least 3 months.
  5. Subject medication that is TBI-related has remained stable for at least 4 weeks prior to baseline data collection;
  6. Current medical options have been tried and documented without sufficient improvement in symptom control;
  7. Subject agrees not to add or increase any medication throughout the randomization period of the study;
  8. Subject is willing to cooperate with the study requirements.

Exclusion Criteria:

  1. Subject diagnosed with a terminal disease (ie. cancer, leukemia, or advanced stages of disease resulting in less than 12 months life expectancy);
  2. Subject currently participating in another clinical study;
  3. Subject with demand-type cardiac pacemakers, an infusion pump or any implantable device (ie. deep brain stimulators, spinal cord stimulators, CSF shunts, aneurism clip and cochlear implants) which may interfere with therapy;
  4. Subject with significant depression and/or other significant psychiatric/behavioral problems likely to interfere with study completion or result in addition distress to the subject as determined by a qualified Psychiatrist or psychologist;
  5. Subject with an existing medical condition that is likely to require repetitive MRI evaluation in the future (ie. epilepsy, stroke, acoustic neuroma, tumor);
  6. Subject with a history of open head trauma;
  7. Subject with visual, hearing or motor deficits that impair ability to complete neurocognitive testing;
  8. Subject with a history of moderate to severe TBI;
  9. Subject with post traumatic seizure disorder;
  10. Subject with history of learning disability and/or ADHD
  11. Subject with history of chronic headache syndrome prior to post-concussive disorder;
  12. Subject is not willing to maintain current TBI-related medication regimen;
  13. Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception (ie. oral contraceptives, injectibles, implants, patches, condoms, barrier methods, spermicides, intrauterine devices, and sterilization), or nursing (lactating) a child.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588691

Locations
United States, California
Kevin Yoo, MD/Palomar Neurosurgery Ctr
Poway, California, United States, 92064
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Roni Diaz St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01588691     History of Changes
Other Study ID Numbers: CRD-517
Study First Received: February 15, 2012
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
Traumatic Brain Injury

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 28, 2014