Mild Traumatic Brain InjuryCN-NINMNCT02125591
Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Full 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 evaluate improvement in balance after receiving physical therapy when augmented by CN-NINM than when augmented by a placebo (sham CN-NINM). 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
- Aug 2015to Dec 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: A Randomized, Double-Blinded, Sham-Controlled, Prospective Trial
The purpose of this study is to evaluate improvement in balance after receiving physical therapy when augmented by CN-NINM than when augmented by a placebo (sham CN-NINM).
- 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 PoNS CN-NINM | 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 | Sham 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.
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
Secondary outcomes (7)
Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI)
Measured: 12 weeks
Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI)
Measured: 12 weeks
Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ)
Measured: 12 weeks
Change in quality of life measured using Short Form 36 (SF-36)
Measured: 12 weeks
Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C)
Measured: 12 weeks
Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI)
DTI will be acquired using 3.0T field strength Siemens Trio MRI scanner.
Measured: 12 weeks
Change in neuroimaging using functional magnetic resonance imaging (fMRI)
For fMRI, a repeated single-shot echo-planar imaging will be acquired
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 posted29 Apr 2014 (estimated)
- Study startAug 2015
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT02125591
- Sponsor's protocol ID
- CN-NINM full
- Acronym
- CN-NINM
- Status last verified
- Oct 2014
- First submitted
- 7 Apr 2014
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 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: A Randomized, Double-Blinded, Sham-Controlled, Prospective Trial
- ClinicalTrials.gov ID
- NCT02125591
- Acronym / sponsor ID
- CN-NINM / CN-NINM full
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- 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
- Aug 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 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 evaluate improvement in balance after receiving physical therapy when augmented by CN-NINM than when augmented by a placebo (sham CN-NINM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PoNS CN-NINM | 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 | Sham 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 PoNS CN-NINM |
| 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
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.
7 secondary outcomes
Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI)
Time frame: 12 weeks
Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI)
Time frame: 12 weeks
Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ)
Time frame: 12 weeks
Change in quality of life measured using Short Form 36 (SF-36)
Time frame: 12 weeks
Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C)
Time frame: 12 weeks
Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI)
Time frame: 12 weeks
Change in neuroimaging using functional magnetic resonance imaging (fMRI)
Time frame: 12 weeks
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 22 May 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 22 May 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?
Change in Sensory Organization Test (SOT) (time frame: 12 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 22 May 2015.