Efficacy of PoNS in Reducing Symptoms of Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Examining the Efficacy of Non-invasive Neuromodulation in Reducing Symptoms of Multiple Sclerosis - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496531
• Other study ID #: MS Pilot - Leonard, et al
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2020
• Source: Neurohabilitation Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years to 62 Years

Eligibility

Inclusion Criteria:

• Relapsing/remitting or secondary progressive MS with balance and gait problems;

• Recent EDSS score of 3.0 - 6.0;

• Provided informed consent and willing to participate

Exclusion Criteria:

• Use of tobacco products;

• Oral health problems including abrasions, cuts, cold sores, piercings, or tissue inflammation in the oral cavity;

• Baseline EDSS >6.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Portable Neuromodulation Stimulator

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Neurohabilitation Corporation	Montreal Neurological Institute, McGill University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Gait Index	Scores are based on a 4-point scale where: 3 = No gait dysfunction; 2 = Minimal impairment; 1 = Moderate impairment; and 0 = Severe impairment. The highest possible score was 24 points. Tasks include: Steady state walking; Walking with changing speeds; Walking with head turns both horizontally and vertically; Walking while stepping over and around obstacles; Pivoting while walking; and Stair climbing.	14 weeks