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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: TRPMS + Aerobic Physical Activity Program | Experimental |
| |
| Arm 2: TRPMS + Adaptive Cognitive Training | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (Day 0), Week 4 |
| Change in Distance Traveled During 2-Minute Walking Test |
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Inclusion Criteria:
In order to be eligible to participate in Arm 1 of this study, an individual must meet all of the following criteria:
In order to be eligible to participate in Arm 2 of this study, an individual must meet all of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Charvet, PhD | NYU Langone Health | Principal Investigator |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
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.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| 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. |
|
| 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 1 |
| 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. | 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. | 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. | 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), 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. | 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. | 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. | Baseline (Day 0), Day 10 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |