Non-Invasive Stimulation for Improving Motor Function
- Conditions
- Spinal Cord Injuries
- Interventions
- Diagnostic Test: Paired TMS & Peripheral Nerve Stimulation
- Registration Number
- NCT03592173
- Lead Sponsor
- Kathleen Friel
- Brief Summary
The purpose of this study is to determine if spinal excitability is increased with a Spinal Associative Stimulation (SAS) protocol, and to determine the functional consequences of this technique on motor recovery.
- Detailed Description
Recovery of motor function continues to be a problem following Spinal Cord Injury. Non-invasive brain stimulation techniques, targeting cortical areas, have been shown to enhance the excitability in the human motor cortex, and these changes in the motor cortex may be of significance for the rehabilitation of brain injured patients. However, little is known about the adaptational changes in the excitability/plasticity of spinal neural circuits in spinal cord injury patients.
The purpose of this study is to investigate the excitability of cortical and spinal inhibitory and excitatory mechanisms before and following a period of repetitive and synchronized dual peripheral nerve and brain stimulation. Repetitive, paired brain and peripheral nerve stimulation as a neuromodulatory tool, paired associative stimulation (PAS), has been well described. In this technique, stimuli are timed such that afferent and efferent volleys interact at the level of the cortex, that lead to a temporary enhancement of Motor Evoked Potential (MEP) amplitude in target muscles, and when applied repeatedly, lead to a sustained effect, outlasting the intervention period. This repetitive technique has been done in healthy subjects and patients with neurological diseases. By modifying the time between paired stimuli, the investigators will generate afferent/efferent interactions in the spinal cord.
The working hypothesis of this study is that the acute facilitation of the H-reflex during Paired TMS and peripheral nerve stimulation, may be harnessed to modulate spinal excitability (sustained increase in the MEP amplitude). That is, the investigators will test if similar to PAS, a change in excitability outlasting the stimulation/intervention period may occur with afferent/efferent interactions, although at the level of the spinal cord rather than the cortex, and be useful to strengthen residual pathways after damage to the spinal cord.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Spinal cord injury subjects with chronic lesions (> 6 months after the injury)
- Motor incomplete lesion, measured by the American Spinal cord Injury Association (ASIA) Impairment Scale (AIS)
- Traumatic cause of lesion; d) Some degree of motor function in the ankle flexor and extensors (Low extremity Motor Score - LEMS≥3).
- Motor and sensory complete lesion (AIS A); LEMS < 3;
- Non-traumatic cause of lesion
- Medically unstable condition
- Other concurrent neurological illness
- Presence of a potential TMS risk factor (detailed below)
Potential TMS risk factor:
- Damaged skin at the site of stimulation
- Presence of an electrically, magnetically or mechanically activated implant
- An intracerebral vascular clip, or any other electrically sensitive support system
- Metal in any part of the body, including metal injury to the eye
- A history of medication-resistant epilepsy in the family
- Past history of seizures or unexplained spells of loss of consciousness.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SAS50 Paired TMS & Peripheral Nerve Stimulation The paired stimulation (SAS) will be comprised of patient adjusted subthreshold TMS (80% of resting motor threshold over optimal site for soleus muscle), delivered 50ms prior to a peripheral nerve stimulus in the popliteal fossa and will be repeated at 0.1 Hz for 15 minutes (90 stimuli pairs). SAS20 Paired TMS & Peripheral Nerve Stimulation The paired stimulation (SAS) will be comprised of patient adjusted subthreshold TMS (80% of resting motor threshold over optimal site for soleus muscle), delivered 20ms prior to a peripheral nerve stimulus in the popliteal fossa and will be repeated at 0.1 Hz for 15 minutes (90 stimuli pairs). SAS0 Paired TMS & Peripheral Nerve Stimulation The paired stimulation (SAS) will be comprised of patient adjusted subthreshold TMS (80% of resting motor threshold over optimal site for soleus muscle), delivered 0ms prior to a peripheral nerve stimulus in the popliteal fossa and will be repeated at 0.1 Hz for 15 minutes (90 stimuli pairs).
- Primary Outcome Measures
Name Time Method Change in H-Reflex Threshold Baseline compared with immediately after intervention Assessment of muscle reaction after stimulation of sensory fibers
- Secondary Outcome Measures
Name Time Method Walking Index for Spinal Cord Injury (WISCI II) Baseline, immediately after intervention This is a functional capacity scale that rank orders ambulation in people with spinal cord injury, by evaluating the amount of physical assistance, braces or devices required to walk 10 meters. Rank scores range from 0-20. A higher score is indicative of more independent ambulation.
Muscle Force Baseline, immediately after intervention Amount of force recorded during maximal voluntary isometric contraction of a grip movement, recorded with a grip strength measurement device.
Anklebot Baseline, immediately after intervention Lower extremity robotic device that provides kinematic evaluation data
Lower Extremity Motor Score (LEMS) Baseline, immediately after intervention Assessment of lower extremity strength in key muscles; maximal score of 50 with 20 or less indicating participant likely has limited ambulation.
Spinal Cord Independence Measure, Version 3 (SCIM III) Baseline, immediately after intervention A disability rating scale developed to specifically address the ability of SCI patients to perform basic activities of daily living independently (including self-care, mobility, respiration and sphincter management)
10 Meter Walk Test Baseline, immediately after intervention Measure of gait speed
Trial Locations
- Locations (1)
Burke Medical Research Institute
🇺🇸White Plains, New York, United States