Non-Invasive Stimulation for Improving Motor Function



Status:Recruiting
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - 80
Updated:1/25/2019
Start Date:July 2013
End Date:December 2019
Contact:Mar Cortes, MD
Email:mac2083@med.cornell.edu
Phone:9143683181

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

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.

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.

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.
We found this trial at
1
site
White Plains, New York 10605
Phone: 914-368-3116
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White Plains, NY
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