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Active, Not Recruiting

NCT Number: NCT03592173

Non-Invasive Stimulation for Improving Motor Function

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Burke Medical Research Institute

White Plains, New York, 10605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paired TMS & Peripheral Nerve Stimulation

Diagnostic Test

Method of assessing neurophysiology and activity of the spinal cord

Primary outcomes

  1. Change in H-Reflex Threshold

    Time frame: Baseline compared with immediately after intervention

    Assessment of muscle reaction after stimulation of sensory fibers

Secondary outcomes

  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 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.

  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

    Amount of force recorded during maximal voluntary isometric contraction of a grip movement, recorded with a grip strength measurement device.

  6. Anklebot

    Time frame: Baseline, immediately after intervention

    Lower extremity robotic device that provides kinematic evaluation data

Sponsors and collaborators

Lead sponsor

Kathleen Friel

Other

Collaborators

  • Burke Medical Research Institute

Registry information

Official study title

Non-Invasive Stimulation for Improving Motor Function in Spinal Cord Injury

Important dates

Study start
2013
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2018
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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