Amyotrophic Lateral Sclerosis (ALS) Clinical Trial
Official title:
Paired Stimulation to Increase Cortical Transmission to Hand Muscles: Pilot Study
Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral
sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits may
be an important method to improve functional recovery.
In this study, the investigators aim to use non-invasive magnetic and electrical stimulation
to strengthen motor circuits between the brain and hands. Magnetic stimulation will be used
over the motor cortex (scalp). Two methods of electrical stimulation will be compared:
stimulation of the median nerve at the wrist; or direct stimulation of the cervical spinal
cord across the skin on the back of the neck. Several different combinations of magnetic and
electrical stimulation will be compared to find the conditions that best strengthen nerve
circuits between the brain and hands - "Fire Together, Wire Together".
PLEASE NOTE, THIS IS A PRELIMINARY STUDY. This study is testing for temporary changes in
nerve transmission and hand function. THERE IS NO EXPECTATION OF LONG-TERM BENEFIT FROM THIS
STUDY. If we see temporary changes in this study, then future studies would focus on how to
prolong that effect.
Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral
sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits
represents a critical method to improve functional recovery. Different forms of magnetic and
electrical stimulation have been used to activate brain, spinal cord, nerve, or muscle
tissue. Although in some cases, surgically implanted electrical stimulation has delivered
tremendous benefit, a non-invasive approach to nerve stimulation is preferable.
In this proposed study, the investigators aim to use non-invasive magnetic and electrical
stimulation to strengthen motor circuits between the brain and hands. Transcranial magnetic
stimulation (TMS) will be combined with either electrical stimulation of the median nerve at
the wrist; or electrical transcutaneous stimulation of the cervical spinal cord. Magnetic and
electrical stimulation will be precisely timed so that the pulses arrive at the target spinal
motor neurons at roughly the same time - this precise timing is responsible for the
phenomenon of "spike timing-dependent plasticity".
Three groups of participants will be studied: individuals with chronic incomplete cervical
SCI (n=12), individuals with definite or probable ALS (n=6), and individuals without
neurological injury or disease (n=12). Subjects with SCI or ALS will have one screening visit
to confirm eligibility for the study. All subjects will then undergo one baseline testing
session followed by 7 sessions of unpaired or paired magnetic and electrical stimulation.
Functional and physiological testing will be conducted prior to each stimulation session,
then at 0, 15, 30, and 90 minutes post each session. Key measures include grip strength
dynamometry, timed performance on a hand dexterity test, amplitude of abductor pollicis
brevis (APB) response to TMS, integrated amplitude of APB F-wave responses, and duration of
the 'cortical silent period' after TMS stimulation during APB contraction.
PLEASE NOTE, THIS IS A PRELIMINARY STUDY. This study is testing for temporary changes in
nerve transmission and hand function. THERE IS NO EXPECTATION OF LONG-TERM BENEFIT FROM THIS
STUDY. If we see temporary changes in this study, then future studies would focus on how to
prolong that effect.
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