Clinical trial NCT04578041: TRPMS to Improve Mobility and Depression in Multiple Sclerosis
Official title: An Open Label Pilot Study to Investigate the Effect of Transcranial Rotating Permanent Magnetic Stimulation (TRPMS) on Gait, Balance and Depression in People With Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Transcranial Rotating Permanent Magnetic Stimulation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to test the efficacy of 10 sessions of Transcranial Rotating Permanent Magnetic Stimulation (TRPMS) paired with aerobic exercise or computerized cognitive training (CT) on mobility and depression symptoms in 40 individuals affected by multiple sclerosis (MS).

Participants in Arm 1 will complete 10x40 minutes daily sessions of TRPMS+aerobic exercise. Participants in Arm 2 will complete TRPMS+computerized CT. Primary outcomes for both arms will be assessed at baseline, at treatment end and after 4-week from the treatment end (follow-up).


Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in Arm 1 of this study, an individual must meet all of the following criteria:

1. Between ages 18 - 70
2. SDMT z-score ≥ -3.0
3. Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition scaled score ≥ 85
4. Definite MS diagnosis as assessed by a licensed physician (all subtypes - RRMS, PPMS, SPMS)
5. Expanded Disability Status Scale (EDSS) ≤ 6.5
6. Clinically stable disease course with absence of relapse within the past 30 days
7. Able to understand the informed consent process and provide consent to participate in the study
8. Complete the TMS screening questionnaire
9. Able to commit to study timeframe
10. Clinically significant gate deviations (T25-FW \> 5.0 seconds)
11. Able to walk independently with or without assistive device (i.e. cane, crutches, or walking frames) for medium distance
12. Able to exercise with seated elliptical machine

In order to be eligible to participate in Arm 2 of this study, an individual must meet all of the following criteria:

1. Between ages 18 - 70
2. SDMT z-score ≥ -3.0
3. Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition scaled score ≥ 85
4. Definite MS diagnosis as assessed by a licensed physician (all subtypes - RRMS, PPMS, SPMS)
5. Expanded Disability Status Scale (EDSS) ≤ 6.5
6. Clinically stable disease course with absence of relapse within the past 30 days
7. Able to understand the informed consent process and provide consent to participate in the study
8. Complete the TMS screening questionnaire
9. Able to commit to study timeframe
10. Elevated symptoms of depression as determined by BDI of ≥ 4

Exclusion Criteria:

1. Visual, auditory or motor deficits that would influence participant safety as assessed by a licensed physician
2. History of seizure or epileptic history as assessed by licensed physician
3. Medication which significantly lower the seizure threshold as assessed by licensed physician
4. Primary psychiatric disorder that would influence ability to participate
5. Uncontrolled headaches and migraine or recent changes in the rate or severity of head pressure, headache, or migraine in the past two weeks
6. History of stroke or head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (e.g. Deep Brain Stimulator) or in the neck (e.g. Vagus Nerve Stimulator)
7. History of uncontrolled or labile hypertension
8. Other serious uncontrolled medical condition or recent medical traumas
9. Presence of metal or electronic implants in the body contraindicated for TMS
10. Alcohol or other substance use disorder
11. Pregnant or breastfeeding
12. History of clinically significant abnormalities on electrocardiogram (EKG) (Arm 1 only)
13. Presence of chronic medical illness and/or severe ataxia (Arm 1 only)
14. Functional surgery for lower limb in the past 6 months (e.g. hip or knee replacement) (Arm 1 only)
15. Lower limb Botulinum toxin injection within the past 2 months (Arm 1 only)

Primary outcomes:
measure: Percent of Sessions Completed
timeFrame: Day 10
measure: Change in Gait Velocity
timeFrame: Baseline (Day 0), Day 10
measure: Change in PROMIS Depression Score
timeFrame: Baseline (Day 0), Day 10
Secondary outcomes:
measure: Change in Gait Velocity
timeFrame: Baseline (Day 0), Week 4
measure: Change in Distance Traveled During 2-Minute Walking Test
timeFrame: Baseline (Day 0), Day 10
measure: Change in the Total Time for Completing the Timed Up and Go (TUG) test
timeFrame: Baseline (Day 0), Day 10
measure: Change in Modified Fatigue Impact Scale (MFIS) Score
timeFrame: Baseline (Day 0), Day 10
measure: Change in Short Form (SF)-36 Score
timeFrame: Baseline (Day 0), Day 10
measure: Change in PROMIS Depression Score
timeFrame: Baseline (Day 0), Week 4
measure: Change in Center for Epidemiological Studies-Depression short form (CESD-10) Score
timeFrame: Baseline (Day 0), Day 10
measure: Change in Patient Health Questionnaire 9 (PHQ-9) Score
timeFrame: Baseline (Day 0), Day 10
measure: Change in Inventory of Depressive Symptomatology Self-Report (IDS-SR) Score
timeFrame: Baseline (Day 0), Day 10
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Leigh Charvet, PhD
role: PRINCIPAL_INVESTIGATOR
References: