Improving Upper Limb Motor Control With Spinal Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Upper Extremity Motor Score (UEMS)
研究概览
简要总结
The goal of this RCT study is to evaluate if combining activity-based therapy (ABT) with transcutaneous spinal cord stimulation (tSCS) can improve recovery of arm and hand movement in people with cervical spinal cord injury (SCI). As secondary aims, the study will also investigate at how this combination approach affects the cortical changes in the somatosensory and motor areas of the brain, as well as in the spinal cord and whether it helps participants use their arms more in daily life.
The main questions relevant to this study are:
- Can the combination of ABT + tSCS improve motor and sensory functions of the arms and hands more than ABT alone during the sub-acute stage after SCI?
- Does ABT + tSCS induce neuroplasticity, that is, changes in the brain and spinal cord activity linked to motor and sensory functions?
- Do participants who receive ABT + tSCS report greater use of their arms in daily activities compared to those who receive ABT only?
In this study, participants will:
- Receive either ABT + tSCS or ABT + sham stimulation (a low-intensity current that does not facilitate the movements)
- Take part in 20 training sessions over 6-8 weeks (3 times per week, 45 min of active training each). During this, they will perform strengthening, task-based training, and motor control strengthening exercises with a therapist.
- Complete clinical tests and neurophysiological assessments (transspinal electrical stimulation, electroencephalography and transcranial magnetic stimulation) at three time points-- at the start, after training, and one month later to measure recovery and brain activity changes.
Researchers will compare the assessment outcomes across the three time points.
详细描述
This RCT study is led by Dorothy Barthélemy (Ph.D, pht, Principal Investigator (PI)), Marika Demers (Ph.D, erg., co-PI), Diana Zidarov (Ph.D, co-PI) and Sujata Sinha (PhD, postdoctoral fellow, project lead). Collaborator includes Victoria Duda (PhD).
Population: individuals with SCI with injury level between C5 and T2, falling into American Spinal Injury Association (ASIA) categories A to D, in the sub-acute phase, and of minimum age of 16 years. These participants are in-patients admitted in the Institut de réadaptation Gingras-Lindsay de Montréal, Canada.
Participants will be randomized (1:1 ratio) into two equal groups, ABT + tSCS and ABT + sham stimulation and stratified based on ASIA level, age and sex.
During the training session, the ABT + tSCS group will receive ABT combined with tSCS. The tSCS will be delivered using surface electrode placed between C4 and T1 as a cathode and self-adhesive surface electrodes placed in the clavicular region on both sides as anodes. tSCS will deliver tonic pulses (30 - 100 Hz) and at an intensity that facilitates voluntary movements (usually 15 mA and up), determined prior to the first training session. Each ABT session will include 5 parts:
- 'Motor control strengthening: equipped with an electronic goniometer, participants control muscle contraction of one joint by following a pattern on a computer screen.
- Cardiovascular warm-up exercises: using equipment that will allow the participant to train their cardiovascular system.
- Weight bearing and stretching exercises: exercises to prepare their upper body muscles for the strengthening exercises.
- Muscle strengthening exercises: exercises to increase their strength, with adapted equipment if necessary.
- Activity-based exercises: exercises composed of repetitive that are present in the participant's daily life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Clinical outcomes assessors and all participants are masked till the end of the study.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic and non-traumatic spinal cord injury
- •Receiving in-patient rehabilitation
- •16 years old or above
- •American Spinal Injury Association (ASIA) grade A to D
- •Neurological injury level between C5 and T2
- •Residual upper limb motor impairments
排除标准
- •Cardiac pacemaker
- •Active cancer at the stimulation site or metastatic cancer
- •Unstable lesion or clinical condition (e.g. respiratory issues)
- •Electrode placement is impossible due to unhealed wound or significant local pain
- •Other Neurological condition (e.g. Stroke, Parkinson's)
- •Chronic liver or kidney disease
- •Uncontrolled psychiatric condition
- •Life expectancy < 6 months
- •Inability to provide informed consent (i.e., severe cognitive impairment, dementia, or Alzheimer's disease)
研究组 & 干预措施
Activity-based therapy with facilitatory spinal stimulation (n=20)
Participants with cervical spinal cord injury (ASIA levels A-D) randomized to this arm will receive real-intensity transcutaneous spinal cord stimulation combined with activity-based therapy. Training will consist of 20 sessions delivered over 6-8 weeks during the subacute stage.
For the transcutaneous spinal cord stimulation (tSCS), a single or two self-adhesive cathode electrodes will be placed at the C4 to T1 vertebral levels. A pair of reference electrodes will be placed bilaterally on the external part of the clavicular regions. The stimulation will be set at minimal intensity, sufficient only for the participants to perceive it. Individualized tSCS parameters (30-80Hz, 0-90mA, biphasic 400us pulse square) will be used to facilitate upper limb movement.
干预措施: Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation (Other)
Activity-based therapy with sham spinal stimulation (n=20)
Participants with cervical spinal cord injury (ASIA levels A-D) randomized to this arm will receive sham transcutaneous spinal cord stimulation combined with activity-based therapy. Training will consist of 20 sessions delivered over 6-8 weeks during the subacute stage.
For the transcutaneous spinal cord stimulation (tSCS), a single or two self-adhesive cathode electrodes will be placed at the C4 to T1 vertebral levels. A pair of reference electrodes will be placed bilaterally on the external part of the clavicular regions. The stimulation will be set at minimal intensity, sufficient only for the participants to perceive it.
干预措施: Protocol 1: Combination of activity-based therapy and sham spinal cord stimulation (Other)
结局指标
主要结局
Upper Extremity Motor Score (UEMS)
时间窗: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
This will be used for assessing the motor function, that is, the strength and functionality of the muscles involved in movement. It helps determine the severity of motor impairments in patients with cervical lesions and is used to track recovery and assess outcome during inpatient rehabilitation. It has high inter-rater and intra-rater reliability. It also has high validity as an impairment measure and has moderate validity for predicting real-world functional independence. The test evaluates five movements of each arm, namely, elbow flexion, wrist extension, elbow extension, middle finger flexion, and little finger abduction. The participant is asked to perform these movements either actively or passively, depending on their ability. These are scored on a scale from 0 (no movement) to 5 (full function). Thus, the higher score reflects improvement in the motor function across the three time frames.
次要结局
- The Prehension subtest of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP- version 2)(3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).)
- Upper-limb sensory score of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)(3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).)
- Grasp and Release Test(3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).)
- Dermatome (sensory) test(3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).)
- Monofilament test(3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).)
- Force (Grip and Pinch Strength) test(3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).)
- Proprioception(3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).)
- Coordination test(3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).)
- Transspinal evoked potentials (TEPs)(3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).)
- Transcranial magnetic stimulation (TMS)- motor evoked potentials(3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).)
- Electrophysiology (EEG)-Somatosensory evoked potentials (SSEPs)(3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).)