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)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Gait Velocity
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change in Gait Velocity
时间窗: 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
时间窗: 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.
Percent of Sessions Completed
时间窗: Day 10
Feasibility of at-home usage of TRPMS device measured by percent of sessions completed (80%)
次要结局
- 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)
- Change in Center for Epidemiological Studies-Depression short form (CESD-10) Score(Baseline (Day 0), Day 10)
- Change in Gait Velocity(Baseline (Day 0), Week 4)
- Change in PROMIS Depression Score(Baseline (Day 0), Week 4)
- Change in Inventory of Depressive Symptomatology Self-Report (IDS-SR) Score(Baseline (Day 0), Day 10)
- Change in Patient Health Questionnaire 9 (PHQ-9) Score(Baseline (Day 0), Day 10)