Clinical trial NCT03592173: Non-Invasive Stimulation for Improving Motor Function
Official title: Non-Invasive Stimulation for Improving Motor Function in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Spinal Cord Injuries
Lead sponsor: Burke Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Burke Medical Research Institute
First posted: 2018-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Thirty chronic SCI participants will given the SAS intervention and a control intervention in a randomized cross-over study, with at least one week between interventions. Each patient will be required to attend the Burke Medical Research Institute on three occasions. We will use a within-subjects design, to test changes in neurophysiologic and voluntary measures after intervention with respect to baseline.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in H-Reflex Threshold
timeFrame: Baseline compared with immediately after intervention
Secondary outcomes:
measure: Lower Extremity Motor Score (LEMS)
timeFrame: Baseline, immediately after intervention
measure: Walking Index for Spinal Cord Injury (WISCI II)
timeFrame: Baseline, immediately after intervention
measure: 10 Meter Walk Test
timeFrame: Baseline, immediately after intervention
measure: Spinal Cord Independence Measure, Version 3 (SCIM III)
timeFrame: Baseline, immediately after intervention
measure: Muscle Force
timeFrame: Baseline, immediately after intervention
measure: Anklebot
timeFrame: Baseline, immediately after intervention
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Medical Research Institute
state: New York
Study officials:
affiliation: Burke Medical Research Institute
name: Kathleen Friel, PhD
role: STUDY_DIRECTOR
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