Multiple Sclerosis
Conditions
Brief 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.
Interventions
Sponsors
McGill University
Helius Medical Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Therapists and other personnel (MR technicians, SOT and DGI administrators, Neuropsychologists etc.) were not informed as to which group a subject belonged. In order to maintain this blinding, both subjects and therapists were instructed not to discuss any details of the stimulus sensation with each other. Additionally, all subjects were instructed not to adjust the stimulus intensity in the presence of therapists. All questions about device use or the stimulation were to be addressed only to the PI
Intervention model description
Fourteen MS patients, seven each in an active and a sham stimulation group, participated. Participants received intensive physical therapy and working memory training for 14 weeks. Functional magnetic resonance imaging (fMRI) using motor imagery and working-memory tasks were completed prior to and following therapy, as were sensory organization tests (SOT), motor performance measures, and neuropsychological assessment.
Eligibility
Sex/Gender
ALL
Age
28 Years to 62 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Gait Index | 14 weeks | 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. |
Outcome results
None listed