Paired Spinal Cord and Peripheral Nerve Stimulation for Hand Function Recovery in Humans Post Cervical SCI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- GRASSP
研究概览
简要总结
Individuals who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. This project aims to test the effects of pairing spinal cord and nerve stimulation combined with physical therapy training in recovering arms and hand function. The long-term goal is to provide better therapies that will improve the ability of individuals with spinal cord injuries to use their arms and hands to perform everyday tasks, similar to injury before.
详细描述
Cervical spinal cord injury (SCI) results in paralysis and/or weakness of arms and hands that severely affects the independence and quality of life post-injury. Therefore, regaining arm and hand function remains the top priority of this population. Considering that SCI is mostly incomplete in nature, recent evidence suggests that physical or occupational therapy training combined with spinal cord transcutaneous stimulation (scTS) is effective in restoring arm and hand function post-cervical SCI. scTS is a non-invasive painless technique that augments the intrinsic capacity of the spinal cord to facilitate motor function post-SCI. The beneficial effects of scTS can be further improved by coupling it with peripheral nerve stimulation (PNS), which supplies the arm and hand muscles.
This study aims to investigate how precisely timed paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS) combined with physical therapy can improve the use of arms and hands in those with a SCI. Spinal cord transcutaneous stimulation (scTS) is a non-invasive electrical stimulation provided on top of the skin over specific areas of the spinal cord to excite the nervous system for the activity being trained and promote connections between the brain and spinal cord. Peripheral nerve stimulation (PNS) is a non-invasive electrical stimulation provided on top of the skin over specific areas of the arm, forearm, and hand to excite the peripheral nerves and promote connections between the spinal cord and the muscles involved in the activity-based recovery training. We hypothesize that precisely timed application of scTS and PNS will increase spinal cord excitability. Increased spinal cord excitability coupled with physical therapy will facilitate hand function recovery post-SCI.
Study aims:
- To establish optimal time sequencing for the paired scTS and PNS delivery resulting in the spinal cord motor neuron excitability in non-injured (NI) and SCI participants.
- To investigate the acute effects of paired scTS and PNS delivery on spinal cord motor neuron and corticospinal excitability.
- To investigate the effectiveness of paired scTS and PNS along with scTS combined with AB-UET in recovering hand function post cervical SCI.
- To identify the potential mechanisms of action underlying the observed changes in the hand function following training with paired scTS and PNS along with scTS combined with AB-UET.
This is a pretest-posttest experimental design. SCI participants will be enrolled for Aims 1, 2, 3 and 4. For SCI participants, On site medical evaluation, ASIA Impairment Scale (ISNCSCI-AIS), MVC grip strength and nerve intactness study will be collected or performed during the screening process. If the individual is potentially eligible for the study, as determined by the study physician and investigators, they will undergo pre-training assessments, 20 training sessions, and post-training assessments. Non-Injured (NI) participants will be enrolled for Aims 1 and 2.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For SCI participants:
- •Inclusion Criteria:
- •At least 18 years of age
- •Non-progressive cervical SCI
- •Greater than or equal to 6-months post spinal cord injury
- •Stable medical condition
- •Viable median and ulnar nerve as evident from MMR and M-Wave recordings
- •Wrist extensor and finger flexors score between 1-3 for both upper extremity for ISNCSCI motor assessment.
排除标准
- •Ventilator Dependent
- •Untreated fracture or pressure ulcer
- •Untreated psychiatric disorder or ongoing drug abuse
- •Cardiac, respiratory, bladder, renal, or other untreated medical disorder unrelated to SCI
- •Skeletal muscle Botox injections less than 6 months prior
- •Previous tendon transfer of the arm or arms
- •Any implanted pump (i.e., baclofen pump, pain pump, etc.) prior to randomization
- •Pregnant at the time of enrollment or planning to become pregnant during the course of the study
- •Unable or unwilling to wean from anti-spasticity medications
- •History of seizure or epilepsy
- •Metal in Head
- •Cochlear implant
- •Implanted brain stimulators
- •Aneurysm clips
- •Increased intracranial pressure (which lowers seizure threshold)
- •Cardiac pacemaker
- •Personal or family history of epilepsy
- •Tricyclic antidepressants or neuroleptics (which lower seizure threshold)
- •For healthy volunteer/participants:
- •Inclusion Criteria:
- •At least 18 years of age
- •Exclusion Criteria:
- •Neurological injury or disease
- •Pregnant at the time of enrollment or planning to become pregnant during the course of the study
- •Personal or family history of seizure or epilepsy
- •Tricyclic antidepressants or neuroleptics (which lower seizure threshold)
结局指标
主要结局
GRASSP
时间窗: From enrollment to the end of treatment at 4 weeks
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is a 3-part assessment designed to measure participant's hand and arm function. The test specifically measures strength, sensation, and prehension. During strength testing, selected upper extremity muscles are assessed for the grade of muscle contraction or power of the muscle. During sensation testing, specific zones on the palmar and dorsal aspects of the hand are tested with Semmes Weinstein Monofilaments (SWM) with varying weights. Prehension is assessed both qualitatively and quantitatively. During the qualitative section, no specific position is required, except that the hand should be positioned appropriately for movement with assistance from the examiner, if necessary. During quantitative section, participant is asked to perform six tasks and performance is graded.
NRS
时间窗: From enrollment to the end of treatment at 4 weeks
Neuromuscular Recovery Scale Assessment (NRS) assesses the level of muscle activation and amount of external assistance required to perform motor tasks involving hand, arm, and trunk. The research participant will be asked to perform motor tasks as independently as possible. Research staff will score each of these tasks based on the algorithm. NRS consists of six sub-items focusing on UE function, including overhead press, shoulder flexion, grasp, door pull, open with key, and can open and manipulation. Items are scored from phase 1 to phase 4, the higher the phase, the better is the functional performance
Voluntary hand opening and closing kinematics
时间窗: From enrollment to the end of treatment at 4 weeks
Three-dimensional kinematic data will be collected using a motion capture system. Reflective markers will be placed on the participant's forearm, hand, and fingers to track wrist and finger movements during a maximum hand opening and closing task. Surface electrodes will be applied on the participant's skin to acquire EMG data.
Maximal voluntary grip strength
时间窗: From enrollment to the end of treatment at 4 weeks
For maximal voluntary grip strength, participants will be instructed to apply as much force as possible while trying to grasp or making a fist around the grip handle during a 3 second audio cue. Each MVC attempt will be followed by a rest period of 20 seconds of no activity. A total of 5 grip strength attempts will be collected.
Transcranial magnetic stimulation motor evoked potential (MEP)
时间窗: From enrollment to the end of treatment at 4 weeks
To obtain MEP, transcortical magnetic stimulation (TMS) will be delivered through a figure-of-eight coil using a monophasic current waveform to the optimal scalp position along the arm and hand representation of the primary motor cortex eliciting largest MEP (MEPmax) from targeted arm and hand muscles. Electromyographic (EMG) sensors will be applied on the participant's skin to acquire muscle data.
F-wave
时间窗: From enrollment to the end of treatment at 4 weeks
120% of the maximum stimulation intensity causing plateauing of the M-wave will be used to elicit F-wave. Evoked responses will be recorded using low-noise, pre-amplified surface EMG electrodes placed on the arm and hand muscles to record signals.
次要结局
- Functional Neurophysiological assessment (FNPA)(From enrollment to the end of treatment at 4 weeks)
- Multisegmental Motor Response (MMR)(From enrollment to the end of treatment at 4 weeks)
- Capabilities of Upper Extremity Questionnaire (CUE-Q)(From enrollment to the end of treatment at 4 weeks)
- Spinal Cord Injury-Quality of Life (SCI-QOL) Questionnaire(From enrollment to the end of treatment at 4 weeks)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) - ASIA Impairment Scale (AIS)(From enrollment to the end of treatment at 4 weeks)
研究者
Pawan Sharma, PT. Ph.D.
Postdoctoral Fellow
Kessler Foundation