TRPMS to Improve Mobility and Depression in Multiple Sclerosis

NCT04578041 | Withdrawn FDA Device

• 1 other identifier: 20-01101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Multiple Sclerosis

Keywords

Transcranial Rotating Permanent Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

• Percent of Sessions Completed

  Feasibility of at-home usage of TRPMS device measured by percent of sessions completed (80%)

  Day 10

• Change in Gait Velocity

  To determine the primary efficacy of the TRPMS intervention paired with aerobic exercise, gait velocity will be assessed during the instrumented 10-meter walking test. Gait velocity will be measured using a wearable inertial sensor (G-Sensor).

  Baseline (Day 0), Day 10

• Change in PROMIS Depression Score

  Arm 2: To determine the primary efficacy of the TRPMS intervention paired with computerized CT, changes in PROMIS Depression from baseline to treatment-end will be measured. The PROMIS Depression questionnaire consists of 8 items. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.

  Baseline (Day 0), Day 10

Secondary Outcomes (9)

• Change in Gait Velocity

  Baseline (Day 0), Week 4

• Change in Distance Traveled During 2-Minute Walking Test

  Baseline (Day 0), Day 10

• Change in the Total Time for Completing the Timed Up and Go (TUG) test

  Baseline (Day 0), Day 10

• Change in Modified Fatigue Impact Scale (MFIS) Score

  Baseline (Day 0), Day 10

• Change in Short Form (SF)-36 Score

  Baseline (Day 0), Day 10

Study Arms (2)

Arm 1: TRPMS + Aerobic Physical Activity Program

EXPERIMENTAL

Device: TRPMS (Transcranial Rotating Permanent Magnet Stimulation); Other: Aerobic Exercise Program

Arm 2: TRPMS + Adaptive Cognitive Training

ACTIVE COMPARATOR

Device: TRPMS (Transcranial Rotating Permanent Magnet Stimulation); Other: Computerized CT (Cognitive Training)

Interventions

TRPMS (Transcranial Rotating Permanent Magnet Stimulation) DEVICE

TRPMS ( is administered through a head cap worn by the participant and controlled by QHTimeStimulate application via computer tablet. * Modality: Excitatory stimulation * Frequency: 5 Hz * Interval between stimulus: 100 ms * Duration of each stimulus: 25 ms * Duration of stimulation: 40 minutes * Position of microstimulators: over primary motor cortex and supplementary motor area for Arm 1; over left and right dorsolateral prefrontal cortex for Arm 2

Arm 1: TRPMS + Aerobic Physical Activity Program; Arm 2: TRPMS + Adaptive Cognitive Training

Aerobic Exercise Program OTHER

Aerobic exercise consisting of 40 minutes of cycling training with a seated elliptical machine. The daily physical activity program will consist of three 10-minute bouts of aerobic exercise interspersed with two 5-minute bouts of rest. The participants will exercise maintaining their Heart Rate (HR) at least between 60-80% of the maximum age-related HR.

Arm 1: TRPMS + Aerobic Physical Activity Program

Computerized CT (Cognitive Training) OTHER

Computerized cognitive training (CT) consisting of 40 minutes Brain-HQ training. The adaptive cognitive training games also serve to engage them during the stimulation session, and to keep them seated at the computer for the entire duration of the session.

Arm 2: TRPMS + Adaptive Cognitive Training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in Arm 1 of this study, an individual must meet all of the following criteria:
• Between ages 18 - 70
• SDMT z-score ≥ -3.0
• Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition scaled score ≥ 85
• Definite MS diagnosis as assessed by a licensed physician (all subtypes - RRMS, PPMS, SPMS)
• Expanded Disability Status Scale (EDSS) ≤ 6.5
• Clinically stable disease course with absence of relapse within the past 30 days
• Able to understand the informed consent process and provide consent to participate in the study
• Complete the TMS screening questionnaire
• Able to commit to study timeframe
• Clinically significant gate deviations (T25-FW \> 5.0 seconds)
• Able to walk independently with or without assistive device (i.e. cane, crutches, or walking frames) for medium distance
• 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:
• Between ages 18 - 70

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Leigh Charvet, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: January 1, 2023
• Primary Completion: March 5, 2023
• Study Completion: March 5, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to leigh.charvet@nyulangone.org To gain access, data requestors will need to sign a data access agreement.