Traumatic Brain Injury Peripheral Nerve Study

NCT01588691 | Completed Phase 1

• 1 other identifier: CRD-517
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Reduction in persistent cognitive impairments

  24 weeks

Study Arms (3)

Low frequency

ACTIVE COMPARATOR

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)

High frequency

ACTIVE COMPARATOR

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)

No stimulation

PLACEBO COMPARATOR

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)

Interventions

Eon-mini IPG (implantable pulse generator) DEVICE

programming parameters set at low frequency. Patients will receive this therapy dose for 3 weeks.

Low frequency

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects able to provide informed consent to participate in the study;
• Subjects between the ages of 18 and 65;
• 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.
• 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.
• Subject medication that is TBI-related has remained stable for at least 4 weeks prior to baseline data collection;
• Current medical options have been tried and documented without sufficient improvement in symptom control;
• Subject agrees not to add or increase any medication throughout the randomization period of the study;
• Subject is willing to cooperate with the study requirements.

You may not qualify if:

• Subject diagnosed with a terminal disease (ie. cancer, leukemia, or advanced stages of disease resulting in less than 12 months life expectancy);
• Subject currently participating in another clinical study;
• 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;
• 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;
• Subject with an existing medical condition that is likely to require repetitive MRI evaluation in the future (ie. epilepsy, stroke, acoustic neuroma, tumor);
• Subject with a history of open head trauma;
• Subject with visual, hearing or motor deficits that impair ability to complete neurocognitive testing;
• Subject with a history of moderate to severe TBI;
• Subject with post traumatic seizure disorder;
• Subject with history of learning disability and/or ADHD
• Subject with history of chronic headache syndrome prior to post-concussive disorder;
• Subject is not willing to maintain current TBI-related medication regimen;
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Kevin Yoo, MD/Palomar Neurosurgery Ctr

Poway, California, 92064, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Roni Diaz

  Abbott Medical Devices

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: May 1, 2012
• Study Start: December 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

US (1)