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Traumatic Brain Injury Peripheral Nerve Study

NCT01588691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-02-04

No results posted yet for this study

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

Interventions

DEVICE

Eon-mini IPG (implantable pulse generator)

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

DEVICE

Eon-mini IPG (implantable pulse generator)

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

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Roni Diaz · Abbott Medical Devices

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-04-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01588691 on ClinicalTrials.gov