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Non-Invasive Stimulation for Improving Motor Function

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ClinicalTrials.gov Identifier: NCT03592173
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
Burke Medical Research Institute
Information provided by (Responsible Party):
Kathleen Friel, Burke Medical Research Institute

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 your motor recovery.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Diagnostic Test: Paired TMS & Peripheral Nerve Stimulation Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Invasive Stimulation for Improving Motor Function in Spinal Cord Injury
Actual Study Start Date : July 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAS20
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).
Diagnostic Test: Paired TMS & Peripheral Nerve Stimulation
Method of assessing neurophysiology and activity of the spinal cord

Active Comparator: SAS0
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).
Diagnostic Test: Paired TMS & Peripheral Nerve Stimulation
Method of assessing neurophysiology and activity of the spinal cord

Active Comparator: SAS50
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).
Diagnostic Test: Paired TMS & Peripheral Nerve Stimulation
Method of assessing neurophysiology and activity of the spinal cord




Primary Outcome Measures :
  1. Change in H-Reflex Threshold [ Time Frame: Baseline compared with immediately after intervention ]
    Assessment of muscle reaction after stimulation of sensory fibers


Secondary Outcome Measures :
  1. Lower Extremity Motor Score (LEMS) [ Time Frame: 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.

  2. Walking Index for Spinal Cord Injury (WISCI II) [ Time Frame: Baseline, immediately after intervention ]
    This is a functional capacity scale designed to measure improvements in ambulation in people with spinal cord injury, by evaluating the amount of physical assistance, braces or devices required to walk 10 meters.

  3. 10 Meter Walk Test [ Time Frame: Baseline, immediately after intervention ]
    Measure of gait speed

  4. Spinal Cord Independence Measure, Version 3 (SCIM III) [ Time Frame: 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)

  5. Muscle Force [ Time Frame: Baseline, immediately after intervention ]
    Recorded during maximal voluntary isometric contraction

  6. Anklebot [ Time Frame: Baseline, immediately after intervention ]
    Lower extremity robotic device that provides kinematic evaluation data



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592173


Contacts
Contact: Mar Cortes, MD 9143683181 mac2083@med.cornell.edu
Contact: Zoe Tsagaris, MS 9145972153 kzt3001@med.cornell.edu

Locations
United States, New York
Burke Medical Research Institute Recruiting
White Plains, New York, United States, 10605
Contact: Kathleen Friel, PhD    914-368-3116    braininjuryclinic@med.cornell.edu   
Sponsors and Collaborators
Kathleen Friel
Burke Medical Research Institute
Investigators
Study Director: Kathleen Friel, PhD Burke Medical Research Institute

Publications:

Responsible Party: Kathleen Friel, Lab Director, Clinical Laboratory for Early Brain Injury Recovery, Burke Medical Research Institute
ClinicalTrials.gov Identifier: NCT03592173     History of Changes
Other Study ID Numbers: BRC391
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers at this time.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries