Evaluating Neuromuscular Stimulation for Restoring Hand Movements
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Hospital, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | September 15, 2017 |
| End Date: | March 31, 2019 |
| Contact: | Richard D Ramdeo |
| Email: | rramdeo1@northwell.edu |
| Phone: | 516-562-3634 |
The specific aim of this study is to evoke functional movement in the hand of both healthy
individuals and individuals diagnosed with a complete (AIS "A") C5 level spinal cord injury.
The primary purpose of this study is to determine the feasibility of achieving refined hand
movements through electrical stimulation of the muscles within the forearm. It is believed
that this study will be able to identify specific stimulation parameters and electrode
spatial configurations responsible for various refined hand movements.
After an eligible individual agrees to participate in this study, s/he will receive
transcutaneous electrical stimulation on the forearm in order to evoke different hand and
finger movements. The precision, specificity, and extent of these movements will be visually
assessed. In order to better evaluate these movements, participants may also be asked to
perform various functional tasks with their hand. The grip strength and evoked forces at the
fingertips will also be measured using sensors. There will be up to 4 study sessions each
week for up to 8 weeks, with each session lasting up to 4 hours. Upon completion of these
study sessions, the individual's participation in the study is considered complete.
individuals and individuals diagnosed with a complete (AIS "A") C5 level spinal cord injury.
The primary purpose of this study is to determine the feasibility of achieving refined hand
movements through electrical stimulation of the muscles within the forearm. It is believed
that this study will be able to identify specific stimulation parameters and electrode
spatial configurations responsible for various refined hand movements.
After an eligible individual agrees to participate in this study, s/he will receive
transcutaneous electrical stimulation on the forearm in order to evoke different hand and
finger movements. The precision, specificity, and extent of these movements will be visually
assessed. In order to better evaluate these movements, participants may also be asked to
perform various functional tasks with their hand. The grip strength and evoked forces at the
fingertips will also be measured using sensors. There will be up to 4 study sessions each
week for up to 8 weeks, with each session lasting up to 4 hours. Upon completion of these
study sessions, the individual's participation in the study is considered complete.
In order to evaluate whether electrical stimulation applied to the muscles within the forearm
can evoke functional movement in the hand, participants will receive transcutaneous
electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.
Participants will be asked to attend up to 4 study sessions a week for up to 8 weeks, with
each session lasting up to 4 hours. At these sessions, electrical pulses will be sent to the
forearm muscles through electrodes placed on the skin. These electrodes may also be
accompanied with a gel or lotion to allow for a better connection of the electrodes to the
skin. The precision, specificity, and extent of hand and finger movements will be visually
assessed in real time and later reassessed on video recordings of the session. The study will
also involve the placement of sensors on the hand and finger to measure the amount of grip
strength and evoked forces. In order to monitor the health of participants, the study will
assess blood pressure and heart rate before, during, and after the electrical stimulation.
Upon completion of these study sessions, the individual's participation in the study is
considered complete.
can evoke functional movement in the hand, participants will receive transcutaneous
electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.
Participants will be asked to attend up to 4 study sessions a week for up to 8 weeks, with
each session lasting up to 4 hours. At these sessions, electrical pulses will be sent to the
forearm muscles through electrodes placed on the skin. These electrodes may also be
accompanied with a gel or lotion to allow for a better connection of the electrodes to the
skin. The precision, specificity, and extent of hand and finger movements will be visually
assessed in real time and later reassessed on video recordings of the session. The study will
also involve the placement of sensors on the hand and finger to measure the amount of grip
strength and evoked forces. In order to monitor the health of participants, the study will
assess blood pressure and heart rate before, during, and after the electrical stimulation.
Upon completion of these study sessions, the individual's participation in the study is
considered complete.
Inclusion Criteria for Health Volunteers:
- Individuals between 18 and 65 years of age
- Individuals without physical disabilities or conditions/diseases that may make them
incapable of completing the physical study tasks or otherwise places them at a greater
risk of harm
- Individuals that are considered English Proficient due to the study requirements to
follow verbal commands during testing sessions
- Individuals that are able to comprehend the study goals and procedures, and are able
to provide informed consent for participation
- Individuals that are willing and able to visit the study center for study procedures,
which will be up to 4 sessions a week for up to 8 weeks at up to 4 hours per session
- Have the ability and willingness to undergo upper limb electrodiagnostic and nerve
conduction studies
- Demonstrate typical amplitude, latency, and conduction velocity in the distal median,
ulnar, and radial nerves of at least one upper limb
Exclusion Criteria for Healthy Volunteers:
- Individuals participating in another research study that may affect the conduct or
results of this study
- Individuals having or exhibiting any of the following:
- Stage III-IV pressure ulcers
- Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain
stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or
other)
- Prior tendon transfer to enhance hand function
- History of autoimmune disease
- Cancer
- Biochemical abnormalities of the liver, kidney, or pancreas
- Prior difficulties or allergy to general anesthesia
- Ventilator dependence
- History of serious mood or thought disorder
- Significant residual clinically evident traumatic brain injury or cognitive
impairment
- Uncontrolled autonomic dysreflexia
- Spasticity in the upper extremities that is uncontrolled by pharmacological
methods
- Individuals with a substance abuse (alcoholism or other) problem
- Individuals using tobacco or marijuana products
- Pregnant women
- Prisoners
Inclusion Criteria for Spinal Cord Injury Participants:
- Individuals between 18 and 65 years of age
- Individuals with AIS grade A traumatic cervical spinal cord injury with stable motor
level of C5 (bilateral) and scores of 0 for other upper limb myotomes from C6-T1 and
be at least one year from initial spinal cord injury
- Individuals that are considered English Proficient due to the study requirements to
follow verbal commands during testing sessions
- Individuals that are able to comprehend the study goals and procedures, and are able
to provide informed consent for participation
- Individuals that are willing and able to visit the study center for study procedures,
which will be up to 4 sessions a week for up to 8 weeks at up to 4 hours per session
- Have the ability and willingness to undergo upper limb electrodiagnostic and nerve
conduction studies
- Demonstrate typical amplitude, latency, and conduction velocity in the distal median,
ulnar, and radial nerves of at least one upper limb (as expected for a person at their
stage of time post spinal cord injury)
Exclusion Criteria for Spinal Cord Injury Participants:
- Individuals participating in another research study that may affect the conduct or
results of this study
- Individuals having or exhibiting any of the following:
- Stage III-IV pressure ulcers
- Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain
stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or
other)
- Prior tendon transfer to enhance hand function
- History of autoimmune disease
- Cancer
- Biochemical abnormalities of the liver, kidney, or pancreas
- Prior difficulties or allergy to general anesthesia
- Ventilator dependence
- History of serious mood or thought disorder
- Significant residual clinically evident traumatic brain injury or cognitive
impairment
- Uncontrolled autonomic dysreflexia
- Spasticity in the upper extremities that is uncontrolled by pharmacological
methods
- Individuals with a substance abuse (alcoholism or other) problem
- Individuals using tobacco or marijuana products
- Pregnant women
- Prisoners
We found this trial at
1
site
350 Community Drive
Manhasset, New York 11030
Manhasset, New York 11030
Principal Investigator: Chad E Bouton, MS
Phone: 516-562-3634
Click here to add this to my saved trials
