Trials / Completed
CompletedNCT04496531
Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis
Examining the Efficacy of Non-invasive Neuromodulation in Reducing Symptoms of Multiple Sclerosis - a Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Helius Medical Inc · Industry
- Sex
- All
- Age
- 28 Years – 62 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this pilot study is to determine whether a program involving both in-lab and at-home training using cranial nerve stimulation (CN-NINM) delivered via the tongue can reduce symptoms of multiple sclerosis (MS) and improve movement control and therefore provide ground work for a controlled clinical trial. The effects of the stimulation will be measured using a variety of standardized tests of movement control and cognitive function, functional brain imaging, and MS-specific surveys of your quality of life.
Detailed description
Fourteen MS patients, seven each in an active and a sham stimulation group are expected to participate. Participants will receive intensive physical therapy and working memory training for 14 weeks. Functional magnetic resonance imaging (fMRI) using motor imagery and working-memory tasks will be completed prior to and following therapy, as will be sensory organization tests (SOT), motor performance measures, and neuropsychological assessment. Prior to the start of CN-NINM training, each participant will undergo baseline evaluations including structural and fMRI, balance tests (SOT), Dynamic Gait Index (DGI), neuropsychological assessment (Handedness; Wechsler Abbreviated Scale of Intelligence (WASI) Vocabulary and Matrix Reasoning; California Verbal Learning Test (CVLT)-11; D-Kefs Trails, Color/Word and Verbal Fluency; Tower of London Second Edition; Ruff 2 and 7; Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Letter-Number sequencing, Coding and Symbol Search; Paced Auditory Serial Addition Test (PASAT); Leonard Tapping; and Grooved Pegboard). In addition, the MS Impairment Scale, Fatigue Impact Scale, Cognitive Function Inventory for MS, and Beck Depression and Anxiety questionnaires will be completed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Portable Neuromodulation Stimulator |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2020-08-03
- Last updated
- 2020-08-05
Source: ClinicalTrials.gov record NCT04496531. Inclusion in this directory is not an endorsement.