Traumatic Brain InjuryPhase 1TBINCT01588691
Traumatic Brain Injury Peripheral Nerve Study
A Phase 1 study testing Eon-mini IPG (implantable pulse generator) in people with Traumatic Brain Injury, run by Abbott Medical Devices at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Eon-mini IPG (implantable pulse generator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kevin Yoo, MD/Palomar Neurosurgery Ctr
Poway, California, 92064
About this study
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
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Eon-mini IPG (implantable pulse generator)
- Keywords
- Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eon-mini IPG (implantable pulse generator)Device
programming parameters set at low frequency. Patients will receive this therapy dose for 3 weeks.
Eon-mini IPG (implantable pulse generator)Device
programming parameters set at high frequency. Patients will receive this therapy dose for 3 weeks.
Eon-mini IPG (implantable pulse generator)Device
programming parameters set at lowest settings to deliver minimal power. Patients will receive this therapy dose for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Eon-mini IPG (implantable pulse generator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in persistent cognitive impairments
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startDec 2011
- Primary completionApr 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roni Diaz, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588691
- Sponsor's protocol ID
- CRD-517
- Acronym
- TBI
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2012
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01588691
- Acronym / sponsor ID
- TBI / CRD-517
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low frequency | Active comparator | Device: Eon-mini IPG (implantable pulse generator)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. |
| High frequency | Active comparator | Device: Eon-mini IPG (implantable pulse generator)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. |
| No stimulation | Placebo comparator | Device: Eon-mini IPG (implantable pulse generator)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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):
- Subjects 12 month post-injury with DSM IV diagnosis of Postconcussive Disorder Research Criteria (see Appendix A for detailed definition):
- Subject medication that is TBI-related has remained stable for at least 4 weeks prior to baseline data collection;
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eon-mini IPG (implantable pulse generator)programming parameters set at low frequency. Patients will receive this therapy dose for 3 weeks. | Device | Low frequency |
| Eon-mini IPG (implantable pulse generator)programming parameters set at high frequency. Patients will receive this therapy dose for 3 weeks. | Device | High frequency |
| 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. | Device | No stimulation |
Primary outcome
Reduction in persistent cognitive impairments
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roni Diaz study director
Abbott Medical Devices
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eon-mini IPG (implantable pulse generator) in people with Traumatic Brain Injury, run by Abbott Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in persistent cognitive impairments (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.