Multiple SclerosisNCT04578041
TRPMS to Improve Mobility and Depression in Multiple Sclerosis
A study testing TRPMS (Transcranial Rotating Permanent Magnet Stimulation), Aerobic Exercise Program and Computerized CT (Cognitive Training) in people with Multiple Sclerosis, run by NYU Langone Health.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- TRPMS (Transcranial Rotating Permanent Magnet Stimulation), Aerobic Exercise Program and Computerized CT (Cognitive Training)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 5 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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)
About this study
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)
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
- Being tested
- TRPMS (Transcranial Rotating Permanent Magnet Stimulation), Aerobic Exercise Program, Computerized CT (Cognitive Training)
- Keywords
- Transcranial Rotating Permanent Magnetic Stimulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Aerobic Exercise ProgramOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: TRPMS + Aerobic Physical Activity Program | Experimental | Not described Receives: Device: TRPMS (Transcranial Rotating Permanent Magnet Stimulation); Other: Aerobic Exercise Program |
| Arm 2: TRPMS + Adaptive Cognitive Training | Active comparator | Not described Receives: Device: TRPMS (Transcranial Rotating Permanent Magnet Stimulation); Other: Computerized CT (Cognitive Training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Sessions Completed
Feasibility of at-home usage of TRPMS device measured by percent of sessions completed (80%)
Measured: 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).
Measured: 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.
Measured: Baseline (Day 0), Day 10
Secondary outcomes (9)
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).
Measured: Baseline (Day 0), Week 4
Change in Distance Traveled During 2-Minute Walking Test
Arm 1
Measured: Baseline (Day 0), Day 10
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.
Measured: Baseline (Day 0), Day 10
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.
Measured: Baseline (Day 0), Day 10
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.
Measured: 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.
Measured: Baseline (Day 0), Week 4
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.
Measured: Baseline (Day 0), Day 10
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.
Measured: Baseline (Day 0), Day 10
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.
Measured: Baseline (Day 0), Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Jan 2023 (estimated)
- Primary completion5 Mar 2023
- Study completion5 Mar 2023
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578041
- Sponsor's protocol ID
- 20-01101
- Status last verified
- Dec 2023
- First submitted
- 1 Oct 2020
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04578041
- Acronym / sponsor ID
- 20-01101
- Conditions
- Multiple Sclerosis
- Keywords
- Transcranial Rotating Permanent Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRPMS (Transcranial Rotating Permanent Magnet Stimulation)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 | Device | Arm 1: TRPMS + Aerobic Physical Activity Program, Arm 2: TRPMS + Adaptive Cognitive Training |
| Aerobic Exercise ProgramAerobic 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. | Other | Arm 1: TRPMS + Aerobic Physical Activity Program |
| Computerized CT (Cognitive Training)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. | Other | Arm 2: TRPMS + Adaptive Cognitive Training |
Primary outcome
Percent of Sessions Completed
Time frame: Day 10
Feasibility of at-home usage of TRPMS device measured by percent of sessions completed (80%)
Change in Gait Velocity
Time frame: Baseline (Day 0), Day 10
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
Time frame: Baseline (Day 0), Day 10
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.
9 secondary outcomes
Change in Gait Velocity
Time frame: Baseline (Day 0), Week 4
Change in Distance Traveled During 2-Minute Walking Test
Time frame: Baseline (Day 0), Day 10
Change in the Total Time for Completing the Timed Up and Go (TUG) test
Time frame: Baseline (Day 0), Day 10
Change in Modified Fatigue Impact Scale (MFIS) Score
Time frame: Baseline (Day 0), Day 10
Change in Short Form (SF)-36 Score
Time frame: Baseline (Day 0), Day 10
Change in PROMIS Depression Score
Time frame: Baseline (Day 0), Week 4
Change in Center for Epidemiological Studies-Depression short form (CESD-10) Score
Time frame: Baseline (Day 0), Day 10
Change in Patient Health Questionnaire 9 (PHQ-9) Score
Time frame: Baseline (Day 0), Day 10
Change in Inventory of Depressive Symptomatology Self-Report (IDS-SR) Score
Time frame: Baseline (Day 0), Day 10
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Charvet, PhD principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A study testing TRPMS (Transcranial Rotating Permanent Magnet Stimulation), Aerobic Exercise Program and Computerized CT (Cognitive Training) in people with Multiple Sclerosis, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Sessions Completed (time frame: Day 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.