Mild Traumatic Brain InjuryNCT02109198
Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Trial)
A study testing Active CN-NINM PoNS in people with Mild Traumatic Brain Injury, run by U.S. Army Medical Research and Development Command at 2 sites in United States.
Trial summary
The purpose of this study is to determine the feasibility of combining PoNS therapy with standard vestibular and balance therapy with the proposed double-blind design; evaluate preliminary indications of efficacy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Active CN-NINM PoNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Aug 2016
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Veteran or Servicemember
- 18 to 50 years old
- Sustained one or more mild traumatic brain injury (mTBI)s
- Demonstration of balance deficits on the Sensory Organization Test (a composite score of 75 or less (1/3 sample) and 72 or less (2/3 sample))
- Available for the duration of the study
Who cannot join
- History of traumatic brain injury (TBI) of any severity other than mild TBI
- Presence of active substance abuse condition
- Any condition for which posturography is contraindicated (e.g. leg amputation or fracture)
- Diagnosed neurological disorder with balance sequelae, other than TBI (e.g. Parkinson's disease, incomplete spinal cord injury, or Multiple Sclerosis)
- Orthostatic hypotension as defined by:
- A systolic blood pressure decrease (from supine to sitting) of at least 20 mmHg
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- A diastolic blood pressure decrease of at least 10 mmHg, or
- A pulse increase of 30 beats or more per minute with associated signs or symptoms of cerebral hypoperfusion
- An implanted medical device
- Pregnancy
- Oral infection
- Known transmissible disease (HIV, hepatitis, influenza, TB)
- Exam signs of serious disorder other than mTBI as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249
Virginia Commonwealth University
Richmond, Virginia, 23298-3038
About this study
Official title: Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Phase)
The purpose of this study is to determine the feasibility of combining PoNS therapy with standard vestibular and balance therapy with the proposed double-blind design; evaluate preliminary indications of efficacy. This study is also evaluating recruitment rate, completion rate, device usability, and outcome measures feasibility.
- Goal for recruitment: 100% of 30 subjects meeting all inclusion criteria can be recruited over the 36 week pilot recruitment phase.
- Completion and compliance: 90% of subjects will complete the study, 90% of sessions within each subject will be completed, and for completing subjects, 100% of measures will be completed.
- Useability: all therapists and subjects must rate useability as good or better.
- Success of blind: subject accuracy at guessing group membership must be at or near 50%.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Active CN-NINM PoNS, Sham CN-NINM PoNS
- Keywords
- Mild Traumatic Brain Injury
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active CN-NINM PoNSDevice
Also called Active cranial-nerve non-invasive neuromodulation (CN-NINM), Portable Neuromodulation Stimulator (PoNS)
Delivery of active stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours.
Sham CN-NINM PoNSDevice
Delivery of sham stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Active CN-NINM PoNS | Experimental | Active CN-NINM PoNS - Active cranial-nerve non-invasive neuromodulation (CN-NINM) using the Portable Neuromodulation Stimulator (PoNS) and balance/gait rehabilitation with physical therapy Receives: Device: Active CN-NINM PoNS |
| Sham PoNS CN-NINM | Placebo comparator | Sham CN-NINM PoNS - Sham cranial-nerve non-invasive neuromodulation (CN-NINM) using the Portable Neuromodulation Stimulator (PoNS) and balance/gait rehabilitation with physical therapy Receives: Device: Sham CN-NINM PoNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number and percentage of subjects recruited over the 36 week pilot recruitment phase
Measured: 36 weeks
Completion and compliance rates
Number and percentage of subjects who complete the study
Measured: Up to 12 weeks
Usability rating
Number and percentage of subjects and therapists who rated usability as good or better.
Measured: 12 weeks
Success of blinding
Number and percentage of subjects who accurately guess group membership
Measured: 12 weeks
Change in Sensory Organization Test (SOT)
Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startJun 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: protocol withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Virginia Commonwealth University, US Department of Veterans Affairs, The Defense and Veterans Brain Injury Center
- Responsible party
- Sponsor
- Investigators
- David X Cifu, MD, Principal investigator, VA Department of Physical Medicine and RehabilitationWilliam C Walker, MD, Principal investigator, Virginia Commonwealth University (VCU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109198
- Sponsor's protocol ID
- CN-NINM pilot
- Status last verified
- May 2015
- First submitted
- 7 Apr 2014
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Phase)
- ClinicalTrials.gov ID
- NCT02109198
- Acronym / sponsor ID
- CN-NINM pilot
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: protocol withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Virginia Commonwealth University, US Department of Veterans Affairs, The Defense and Veterans Brain Injury Center
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 9 Apr 2014 (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.
The purpose of this study is to determine the feasibility of combining PoNS therapy with standard vestibular and balance therapy with the proposed double-blind design; evaluate preliminary indications of efficacy. This study is also evaluating recruitment rate, completion rate, device usability, and outcome measures feasibility.
- Goal for recruitment: 100% of 30 subjects meeting all inclusion criteria can be recruited over the 36 week pilot recruitment phase.
- Completion and compliance: 90% of subjects will complete the study, 90% of sessions within each subject will be completed, and for completing subjects, 100% of measures will be completed.
- Useability: all therapists and subjects must rate useability as good or better.
- Success of blind: subject accuracy at guessing group membership must be at or near 50%.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active CN-NINM PoNS | Experimental | Device: Active CN-NINM PoNSActive CN-NINM PoNS - Active cranial-nerve non-invasive neuromodulation (CN-NINM) using the Portable Neuromodulation Stimulator (PoNS) and balance/gait rehabilitation with physical therapy |
| Sham PoNS CN-NINM | Placebo comparator | Device: Sham CN-NINM PoNSSham CN-NINM PoNS - Sham cranial-nerve non-invasive neuromodulation (CN-NINM) using the Portable Neuromodulation Stimulator (PoNS) and balance/gait rehabilitation with physical therapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Veteran or Servicemember
- 18 to 50 years old
- Sustained one or more mild traumatic brain injury (mTBI)s
- Demonstration of balance deficits on the Sensory Organization Test (a composite score of 75 or less (1/3 sample) and 72 or less (2/3 sample))
- Available for the duration of the study
Key exclusion criteria (13 listed)
- History of traumatic brain injury (TBI) of any severity other than mild TBI
- Presence of active substance abuse condition
- Any condition for which posturography is contraindicated (e.g. leg amputation or fracture)
- Diagnosed neurological disorder with balance sequelae, other than TBI (e.g. Parkinson's disease, incomplete spinal cord injury, or Multiple Sclerosis)
- Orthostatic hypotension as defined by:
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 |
|---|---|---|
| Active CN-NINM PoNSAlso: Active cranial-nerve non-invasive neuromodulation (CN-NINM), Portable Neuromodulation Stimulator (PoNS)Delivery of active stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours. | Device | Active CN-NINM PoNS |
| Sham CN-NINM PoNSDelivery of sham stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours. | Device | Sham PoNS CN-NINM |
Primary outcome
Recruitment rate
Time frame: 36 weeks
Number and percentage of subjects recruited over the 36 week pilot recruitment phase
Completion and compliance rates
Time frame: Up to 12 weeks
Number and percentage of subjects who complete the study
Usability rating
Time frame: 12 weeks
Number and percentage of subjects and therapists who rated usability as good or better.
Success of blinding
Time frame: 12 weeks
Number and percentage of subjects who accurately guess group membership
Change in Sensory Organization Test (SOT)
Time frame: 12 weeks
Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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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.
David X Cifu, MD principal investigator
VA Department of Physical Medicine and Rehabilitation
William C Walker, MD principal investigator
Virginia Commonwealth University (VCU)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active CN-NINM PoNS in people with Mild Traumatic Brain Injury, run by U.S. Army Medical Research and Development Command at 2 sites 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 5 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: withdrawn, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Recruitment rate (time frame: 36 weeks). The study lists 5 primary outcomes in all. 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 2 Jun 2015.