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临床试验/NCT06413602
NCT06413602进行中(未招募)不适用

Exploring the Synergistic Effects of AIH and FES in Persons With MS

Shirley Ryan AbilityLab1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Motor Evoked Potentials (MEPs) in Ankle Dorsiflexors

研究概览

简要总结

The purpose of this study is to examine how neuromuscular electrical stimulation (NMES), may synergistically enhance corticospinal excitability in people with relapsing form multiple sclerosis (MS). This is an important intermediate step to evaluate the potential of AIH + NMES as a plasticity-priming strategy for more efficacious interventions for persons with MS. This study will measure ankle torque generation and amplitude of motor evoked potentials (MEPs) using a repeated measures study design in order to better understand the effects of AIH combined with NMES, as compared to only receiving NMES, and only receiving AIH.

详细描述

NMES: NMES refers to the application of mild electrical stimulation and is often used as an assistive technology for foot drop in MS and other neurologic conditions. The NMES-induced improvement in motor performance appears to be mediated primarily by an increase in corticomotoneuronal excitability. A single session of NMES applied over a peripheral nerve, has been shown to transiently increase net corticospinal excitability (increased MEP amplitude) in both able-bodied individuals and in people with neurological conditions.

AIH: AIH involves breathing brief bouts of low levels of oxygen. Research has found AIH to be a safe and effective intervention resulting in increased ankle strength in people with MS. While AIH has shown potential in enhancing neuroplasticity in people with spinal cord injury (SCI), it has yet to be studied extensively in MS. Preliminary research in the MS population demonstrates that a single session of AIH enhances motor output, increasing voluntary muscle strength by as much as 15-20% within 60 minutes. Over the past decade, studies have found AIH can rapidly enhance neural plasticity in persons with incomplete SCI. AIH activates the serotonergic pathway, leading to increased activity of serotonin receptors and the synthesis of plasticity-related proteins. This plasticity is manifested by a rapid increase in voluntary muscle strength, emerging within 60-90 minutes.

In this study, the investigators will examine how NMES, which has been shown to affect cortical excitability, and AIH, which has been shown to affect corticospinal plasticity, may synergistically enhance corticospinal excitability in people with relapsing form of MS. Foot drop is a common symptom in the diagnosis of MS where the inability to maintain active dorsiflexion during the swing phase of the gait cycle affects walking efficiency, instability, and falls. Seminal studies show that individuals with MS retain the ability to express plasticity even at higher levels of disease burden. This indicates that strategies targeting neuroplasticity can be used to enhance functional recovery and limit the impact of MS disability. The investigators will conduct a randomized, blinded, placebo-controlled, cross-over study in 20 MS patients with established motor deficits and controlled relapse activity and 20 control subjects with no neurological diagnosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for persons with MS:
  • Diagnosis of relapsing form of MS
  • Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5
  • Relapse free for at least 1 year
  • Age ≥18 years and ≤75 years
  • No change in Dalfampridine dose at least 2 months prior to enrollment

排除标准

  • for persons with MS:
  • Uncontrolled hypertension or hypotension (outside 140/90 and 90/60 mmHg)
  • History of epilepsy or seizures
  • Inclusion Criteria for uninjured controls:
  • Age ≥18 years and ≤75 years
  • Safe to participate in TMS (TMS questionnaire)
  • Exclusion Criteria for uninjured controls:
  • Uncontrolled hypertension or hypotension (outside 140/90 and 90/60 mmHg)
  • History of epilepsy or seizures
  • Exclusion criteria to TMS participation for persons with MS and uninjured controls:
  • Uncontrolled medical problems affecting the lungs (pulmonary diseases including chronic obstructive pulmonary disease), the heart (cardiovascular diseases) or the musculoskeletal system (orthopedic diseases)
  • Premorbid, ongoing major depression or psychosis, altered cognitive status
  • History of stroke
  • Metal in head (e.g., surgical clips, shrapnel)
  • History of seizures or epilepsy diagnosis
  • Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
  • Surgery to the head
  • Any non-MS related neurological diseases
  • Illnesses that may have caused brain injury
  • Unexplained frequent or severe headaches
  • Pregnancy in females
  • Implanted devices (e.g., pacemakers, medical pumps, brain stimulators)
  • Unable to participate in TMS

研究组 & 干预措施

AIH alone

Experimental

Participants will undergo 30 minutes of AIH.

干预措施: Acute Intermittent Hypoxia (Other)

NMES alone

Experimental

Participants will undergo repetitive common peroneal nerve stimulation for up to 30 minutes.

干预措施: Neuromuscular Electrical Stimulation (Other)

Combined AIH and NMES

Experimental

Participants will undergo 30 minutes of AIH. Immediately following, participants will undergo NMES for up to 30 minutes.

干预措施: Acute Intermittent Hypoxia (Other)

Combined AIH and NMES

Experimental

Participants will undergo 30 minutes of AIH. Immediately following, participants will undergo NMES for up to 30 minutes.

干预措施: Neuromuscular Electrical Stimulation (Other)

结局指标

主要结局

Motor Evoked Potentials (MEPs) in Ankle Dorsiflexors

时间窗: Immediately prior to and within 60 minutes after the intervention.

The MEPs will be elicited by Transcranial Magnetic Stimulation (TMS), a procedure that uses magnetic fields to stimulate nerve cells in the brain.

次要结局

  • Ankle Dorsiflexion Torque(Immediately prior to and within 60 minutes after the intervention.)
  • Ankle Dorsiflexion EMG(Immediately prior to and within 60 minutes after the intervention.)
  • Symbol Digit Modalities Test(Immediately prior to and within 60 minutes after the intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Milap Sandhu

Principal Investigator

Shirley Ryan AbilityLab

研究点 (1)

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