Comparative Evaluation of Non-Invasive Neuromodulation Therapies to Restore Upper Extremity Function in Chronic Cervical Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
研究概览
简要总结
This study explores two promising therapies for restoring arm and hand function in people with chronic cervical spinal cord injury (SCI), a condition that affects independence and quality of life. It will compare transcutaneous spinal cord stimulation and paired corticospinal-motoneuronal stimulation, both combined with rehabilitation. Using a crossover design, participants will receive each therapy for two months, with a one-month washout period in between. Safety, effectiveness, and patient-reported outcomes like daily living ability and quality of life will be assessed, alongside changes in neural excitability. The results of this study may enable us to tailor treatments to individual needs, promoting personalized care and improved outcomes.
详细描述
Project Aims
The key objective of this pilot is to explore the feasibility of a comparative trial between two non-invasive neuromodulatory approaches for restoration of upper extremity function after SCI, and to work towards the identification of participant cohorts most suited for each intervention (i.e. responders). This objective will be achieved through the following:
- Evaluation of clinical safety and effectiveness of each intervention, within participants, through safety monitoring and the use of standardized assessments of upper extremity strength, sensation and movement performance.
- Evaluation of clinically meaningful improvements through participant reported outcomes related to activities of daily living, QoL and global impressions of change.
- Neurophysiological assessments to assess the mechanisms of recovery following each interventional period, but also to aid in the identification of neurophysiological correlates of "responders" to each therapy.
In this randomized crossover study, participants will receive two months of non-invasive tSCS over the cervical spinal cord in combination with functional task practice (minimum of 12 sessions/month) preceded or followed by two months of PCMS and functional task practice, with a 4-week washout period between each intervention. With this design we will be able to examine the relative efficacy of each paradigm within a single participant and begin to identify neurophysiological and/or clinical characteristics that may help to guide the clinical identification of suitable participants for each intervention.
The minimum training dose for each interventional block is 12 sessions/month, for a total of 24 sessions of training during each treatment phase. Participants will be invited to complete up to 5 sessions per week if feasible. Participants will be required to complete a comparable number of intervention sessions (i.e., within 10%) in each of the two interventions to ensure that any effects are not attributed to differences in dosage. Each intervention session will include at least 60 minutes of upper extremity functional task practice (FTP). The FTP will be completed with typical rehabilitation activities (e.g., range of motion, strengthening activities, moving paperclips, clothespins, cups, etc.) as well as the ReJoyce rehabilitation workstation (Rehabtronics, Alberta), which incorporates computer games into the rehabilitation activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Cervical (C2-C8) level SCI
- •> 9 months post-injury
- •Traumatic SCI
- •Stable dose of anti-spasmodics
排除标准
- •individuals with injury to the nervous system other than to the spinal cord
研究组 & 干预措施
Cervical Transcutaneous Spinal Cord Stimulation with Functional Task Practice
Cervical transcutaneous spinal cord stimulation will be delivered following previously reported guidelines. Circular (1.25") electrodes will be placed over the cervical spinal cord between the C3 and C4 vertebral level, with rectangular return electrodes placed either over the clavicles or iliac crests. Biphasic stimulation will be delivered continuously at 30Hz, with a 1ms pulse width, and overlapping 10kHz carrier frequency (Gelenitis et al 2024; Moritz et al 2024). Stimulation will be delivered at a current intensity below motor threshold, that is below the intensity required to elicit a muscle twitch. Cervical tSCS will be delivered for at least 60 minutes during each training session, and FTP will occur during the active stimulation.
干预措施: Transcutaneous Cervical Spinal Cord Stimulation (Other)
Cervical Transcutaneous Spinal Cord Stimulation with Functional Task Practice
Cervical transcutaneous spinal cord stimulation will be delivered following previously reported guidelines. Circular (1.25") electrodes will be placed over the cervical spinal cord between the C3 and C4 vertebral level, with rectangular return electrodes placed either over the clavicles or iliac crests. Biphasic stimulation will be delivered continuously at 30Hz, with a 1ms pulse width, and overlapping 10kHz carrier frequency (Gelenitis et al 2024; Moritz et al 2024). Stimulation will be delivered at a current intensity below motor threshold, that is below the intensity required to elicit a muscle twitch. Cervical tSCS will be delivered for at least 60 minutes during each training session, and FTP will occur during the active stimulation.
干预措施: Functional Task Practice (Other)
Paired Corticospinal Motoneuronal Stimulation with Functional Task Practice
Paired transcranial magnetic stimulation and nerve stimulation will be implemented following a previously-published protocol for individuals with SCI (Jo et al 2023). Two figure-eight coils will be used to deliver bilateral magnetic stimulation of the motor cortex and will be combined with synchronous electrical stimulation of the brachial plexus and ulnar nerves, bilaterally. The timing of stimuli will be determined to ensure that electrical volleys arrive at the corticospinal motoneuronal synapse at an appropriate interval to induce long term potentiation. During each session, 360 paired stimuli will be delivered at a frequency of 0.2 Hz. The stimulation paradigm should take approximately 30 minutes. Following this, participants will then complete 60 minutes of FTP.
干预措施: Paired Corticospinal Motoneuronal Stimulation (Other)
Paired Corticospinal Motoneuronal Stimulation with Functional Task Practice
Paired transcranial magnetic stimulation and nerve stimulation will be implemented following a previously-published protocol for individuals with SCI (Jo et al 2023). Two figure-eight coils will be used to deliver bilateral magnetic stimulation of the motor cortex and will be combined with synchronous electrical stimulation of the brachial plexus and ulnar nerves, bilaterally. The timing of stimuli will be determined to ensure that electrical volleys arrive at the corticospinal motoneuronal synapse at an appropriate interval to induce long term potentiation. During each session, 360 paired stimuli will be delivered at a frequency of 0.2 Hz. The stimulation paradigm should take approximately 30 minutes. Following this, participants will then complete 60 minutes of FTP.
干预措施: Functional Task Practice (Other)
结局指标
主要结局
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
时间窗: Baseline, 2 months (end of block 1), 3 months (start of block 2), 5months (end of block 2) and 8 months (follow-up)
The ISNCSCI and its associated subscores related to upper extremity motor and sensory scores will be completed by a blinded assessor.
Graded Redefined Assessment of Strength Sensation and Performance (GRASSP)
时间窗: Baseline, 2 months (end of block 1), 3 months (start of block 2), 5months (end of block 2) and 8 months (follow-up)
The GRASSP will be assessed by a blinded assessor to evaluate changes in strength, sensation and performance of the upper extremities.
次要结局
- Spinal excitability - Cervical Multisegmental Motor Responses (cMMR)(Baseline, 1 month (mid-block 1), 2 months (end of block 1), 3 months (start of block 2), 4 months (mid block 2), 5months (end of block 2) and 8 months (follow-up))
- Corticospinal Excitability-Transcranial magnetic stimulation (TMS)(Baseline, 1 month (mid-block 1), 2 months (end of block 1), 3 months (start of block 2), 4 months (mid block 2), 5months (end of block 2) and 8 months (follow-up))