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

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02109198
• Other study ID #: CN-NINM pilot
• Status: Withdrawn
• Phase: N/A
• First received: April 7, 2014
• Last updated: May 29, 2015
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: May 2015
• 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 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%.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2016
• Est. primary completion date: August 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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

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	Recruitment rate	Number and percentage of subjects recruited over the 36 week pilot recruitment phase	36 weeks	No
Primary	Completion and compliance rates	Number and percentage of subjects who complete the study	Up to 12 weeks	Yes
Primary	Usability rating	Number and percentage of subjects and therapists who rated usability as good or better.	12 weeks	No
Primary	Success of blinding	Number and percentage of subjects who accurately guess group membership	12 weeks	No
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