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

Not Applicable

Withdrawn

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT02109198
• Lead Sponsor: U.S. Army Medical Research and Development Command

Brief 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. 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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-09
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Study Start: 2015-06
• Last Update Posted: 2015-06-02
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment rate	36 weeks	Number and percentage of subjects recruited over the 36 week pilot recruitment phase
Completion and compliance rates	Up to 12 weeks	Number and percentage of subjects who complete the study
Usability rating	12 weeks	Number and percentage of subjects and therapists who rated usability as good or better.
Success of blinding	12 weeks	Number and percentage of subjects who accurately guess group membership
Change in Sensory Organization Test (SOT)	12 weeks	Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.

Trial Locations

Locations (2)

McGuire Veterans Affairs Medical Center; 🇺🇸 Richmond, Virginia, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States