Back to resultsTRPMS to Improve Mobility and Depression in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TRPMS (Transcranial Rotating Permanent Magnet Stimulation)
Aerobic Exercise Program
Computerized CT (Cognitive Training)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Transcranial Rotating Permanent Magnetic Stimulation
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:
- 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
- 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
- Elevated symptoms of depression as determined by BDI of ≥ 4
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1: TRPMS + Aerobic Physical Activity Program
Arm 2: TRPMS + Adaptive Cognitive Training
Arm Description
Outcomes
Primary Outcome Measures
Percent of Sessions Completed
Feasibility of at-home usage of TRPMS device measured by percent of sessions completed (80%)
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).
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.
Secondary Outcome Measures
Change in Gait Velocity
Arm 1: To assess sustained improvements, gait velocity will be assessed during the instrumented 10-meter walking test. Gait velocity will be measured using a wearable inertial sensor (G-Sensor).
Change in Distance Traveled During 2-Minute Walking Test
Arm 1
Change in the Total Time for Completing the Timed Up and Go (TUG) test
Arm 1: The test requires the subject to rise from a chair, walk 3.0 m at a comfortable pace to a mark placed on the floor, turn around at the 3.0 m mark, walk back to the starting point, and return to sitting in the chair.
Change in Modified Fatigue Impact Scale (MFIS) Score
MFIS consists of 21 statements that describe the effects of fatigue. Each statement is scored on a scale of 0-4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = almost always). The total MFIS score can range from 0-84; the higher the score, the stronger the feelings of fatigue.
Change in Short Form (SF)-36 Score
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
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.
Change in Center for Epidemiological Studies-Depression short form (CESD-10) Score
Arm 2: CESD-10 10-item Likert scale questionnaire assessing depressive symptoms in the past week. It includes three items on depressed affect, five items on somatic symptoms, and two on positive affect. Options for each item range from "rarely or none of the time" (score of 0) to "all of the time" (score of 3). The total range of score is 0-30; higher scores indicate the presence of significant depressive symptoms.
Change in Patient Health Questionnaire 9 (PHQ-9) Score
Arm 2: The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). A PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Change in Inventory of Depressive Symptomatology Self-Report (IDS-SR) Score
Arm 2: Each of the 28 items is scored on a 1 to 3 scale (0-the absence of pathology; 3-severe pathology). The total scores range from 0 to 84. The higher the score, the more severe the pathology.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04578041
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Transcranial Rotating Permanent Magnetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: TRPMS + Aerobic Physical Activity Program
Arm Type
Experimental
Arm Title
Arm 2: TRPMS + Adaptive Cognitive Training
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
TRPMS (Transcranial Rotating Permanent Magnet Stimulation)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Computerized CT (Cognitive Training)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of Sessions Completed
Description
Feasibility of at-home usage of TRPMS device measured by percent of sessions completed (80%)
Time Frame
Day 10
Title
Change in Gait Velocity
Description
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).
Time Frame
Baseline (Day 0), Day 10
Title
Change in PROMIS Depression Score
Description
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.
Time Frame
Baseline (Day 0), Day 10
Secondary Outcome Measure Information:
Title
Change in Gait Velocity
Description
Arm 1: To assess sustained improvements, gait velocity will be assessed during the instrumented 10-meter walking test. Gait velocity will be measured using a wearable inertial sensor (G-Sensor).
Time Frame
Baseline (Day 0), Week 4
Title
Change in Distance Traveled During 2-Minute Walking Test
Description
Arm 1
Time Frame
Baseline (Day 0), Day 10
Title
Change in the Total Time for Completing the Timed Up and Go (TUG) test
Description
Arm 1: The test requires the subject to rise from a chair, walk 3.0 m at a comfortable pace to a mark placed on the floor, turn around at the 3.0 m mark, walk back to the starting point, and return to sitting in the chair.
Time Frame
Baseline (Day 0), Day 10
Title
Change in Modified Fatigue Impact Scale (MFIS) Score
Description
MFIS consists of 21 statements that describe the effects of fatigue. Each statement is scored on a scale of 0-4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = almost always). The total MFIS score can range from 0-84; the higher the score, the stronger the feelings of fatigue.
Time Frame
Baseline (Day 0), Day 10
Title
Change in Short Form (SF)-36 Score
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time Frame
Baseline (Day 0), Day 10
Title
Change in PROMIS Depression Score
Description
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.
Time Frame
Baseline (Day 0), Week 4
Title
Change in Center for Epidemiological Studies-Depression short form (CESD-10) Score
Description
Arm 2: CESD-10 10-item Likert scale questionnaire assessing depressive symptoms in the past week. It includes three items on depressed affect, five items on somatic symptoms, and two on positive affect. Options for each item range from "rarely or none of the time" (score of 0) to "all of the time" (score of 3). The total range of score is 0-30; higher scores indicate the presence of significant depressive symptoms.
Time Frame
Baseline (Day 0), Day 10
Title
Change in Patient Health Questionnaire 9 (PHQ-9) Score
Description
Arm 2: The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). A PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Time Frame
Baseline (Day 0), Day 10
Title
Change in Inventory of Depressive Symptomatology Self-Report (IDS-SR) Score
Description
Arm 2: Each of the 28 items is scored on a 1 to 3 scale (0-the absence of pathology; 3-severe pathology). The total scores range from 0 to 84. The higher the score, the more severe the pathology.
Time Frame
Baseline (Day 0), Day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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:
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
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
Elevated symptoms of depression as determined by BDI of ≥ 4
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leigh Charvet, PhD
Phone
929-455-5141
Email
Leigh.charvet@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Charvet, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing 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
IPD Sharing 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.
Learn more about this trial
TRPMS to Improve Mobility and Depression in Multiple Sclerosis
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