Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Full Trial)

Mild Traumatic Brain Injury Clinical Trial

— CN-NINM  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02125591
• Other study ID #: CN-NINM full
• Status: Withdrawn
• Phase: N/A
• First received: April 7, 2014
• Last updated: May 21, 2015
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2014
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Veteran or Servicemember

2. 18 to 50 years old

3. Sustained one or more mild traumatic brain injury (mTBI)s

4. 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))

5. Available for the duration of the study

Exclusion Criteria:

1. History of traumatic brain injury (TBI) of any severity other than mild TBI

2. Presence of active substance abuse condition

3. Any condition for which posturography is contraindicated (e.g. leg amputation or fracture)

4. Diagnosed neurological disorder with balance sequelae, other than TBI (e.g. Parkinson's disease, incomplete spinal cord injury, or Multiple Sclerosis)

5. Orthostatic hypotension as defined by:

1. A systolic blood pressure decrease (from supine to sitting) of at least 20 mmHg

2. A diastolic blood pressure decrease of at least 10 mmHg, or

3. A pulse increase of 30 beats or more per minute with associated signs or symptoms of cerebral hypoperfusion

6. An implanted medical device

7. Pregnancy

8. Oral infection

9. Known transmissible disease (HIV, hepatitis, influenza, TB)

10. Exam signs of serious disorder other than mTBI as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Mild Traumatic Brain Injury

Intervention

Device:
• Active CN-NINM 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 PoNS
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.

Locations

Country	Name	City	State
United States	McGuire Veterans Affairs Medical Center	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	The Defense and Veterans Brain Injury Center, VA Office of Research and Development, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sensory Organization Test (SOT)	Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.	12 weeks	No
Secondary	Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI)		12 weeks	No
Secondary	Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI)		12 weeks	No
Secondary	Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ)		12 weeks	No
Secondary	Change in quality of life measured using Short Form 36 (SF-36)		12 weeks	No
Secondary	Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C)		12 weeks	No
Secondary	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.	12 weeks	No
Secondary	Change in neuroimaging using functional magnetic resonance imaging (fMRI)	For fMRI, a repeated single-shot echo-planar imaging will be acquired	12 weeks	No