Healthy VolunteersEarly Phase 1NCT03385005
Evaluating Neuromuscular Stimulation for Restoring Hand Movements
A Early Phase 1 study testing Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator. in people with Healthy Volunteers and Spinal Cord Injury Cervical, run by Northwell Health at 1 site in United States.
Trial summary
The specific aim of this study is to evoke functional movement in the hand of both healthy individuals and individuals diagnosed with a stable cervical spinal cord injury with non-functional movement of the fingers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Spinal Cord Injury Cervical, Physical and Rehabilitation Medicine
- What is being tested?
- Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 1 Oct 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 43Show fewer
- 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
- Pregnant women
- Prisoners
- Inclusion Criteria for Participants with a Spinal Cord Injury:
- Individuals between 18 and 65 years of age
- Individuals with a stable cervical spinal cord injury with ISNCSCI motor scores for fingers of 0 - 2 (non-functional), and 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 Participants with a Spinal Cord Injury:
- 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
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwell Health's The Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
The specific aim of this study is to evoke functional movement in the hand of both healthy individuals and individuals diagnosed with a stable cervical spinal cord injury with non-functional movement of the fingers. 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.
Read the detailed description
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.
- Being tested
- Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.
- Keywords
- Physical and Rehabilitation Medicine, Transcutaneous Electrical Nerve Stimulation, Healthy Volunteer, Spinal Cord Injury, Biomedical Engineering
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.Device
The study involves the administration of various electrical pulses being delivered to muscles of the forearm from a neuromuscular stimulator in order to evoke different hand and finger movements. The grip strength and evoked forces at the fingertips will also be measured using sensors.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Active comparator | This arm consists of healthy volunteers receiving electrical stimulation of the muscles within the forearm via an investigational (not FDA approved) neuromuscular stimulator. Receives: Device: Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator. |
| Spinal Cord Injury Participants | Active comparator | This arm consists of spinal cord injury participants receiving electrical stimulation of the muscles within the forearm via an investigational (not FDA approved) neuromuscular stimulator. Receives: Device: Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm, as assessed by visual inspection.
The primary outcome measure will be achievable wrist and finger movements that will be visually assessed for the type and extent of motion in relation to the stimulation parameters and electrode spatial configurations. The extent of wrist, forearm, and individual finger movements will be categorized as either flexion, extension, adduction, abduction, pronation, or supination and graded as no movement, slight movement, moderate movement, or substantial movement.
Measured: This outcome measure will be assessed at each study session throughout the 8-week duration of the study.
The primary outcome of the study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm, as assessed by force sensors.
The primary outcome measure will be achievable wrist and finger movements that will be assessed by the exerted force (measured in Newtons by force sensors on the fingers and palm) in each of the flexion, extension, adduction, abduction, pronation, or supination movements. This will provide the magnitude of the movement in relation to the stimulation parameters and electrode spatial configurations.
Measured: This outcome measure will be assessed at each study session throughout the 8-week duration of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start15 Sep 2017
- Primary completion7 Dec 2020
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study will involve 3-10 eligible healthy volunteers and 2-5 eligible individuals with a stable cervical spinal cord injury. The study will first enroll healthy volunteers into the study in order to determine the feasibility of evoking refined hand movements through electrical stimulation, and determine the electrical stimulation parameters and electrode spatial configurations responsible for various hand movements. After this is done, the study will proceed with the enrollment of individuals with spinal cord injuries. This enrollment process is being done to reduce the participation time required for participants with a spinal cord injury, and thus lower the likelihood of risks that are more prevalent among individuals with a spinal cord injury.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chad Bouton, Northwell Health
- Investigators
- Chad E Bouton, MS, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385005
- Sponsor's protocol ID
- 17-0070
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2017
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The identifiable information collected on this study will only be shared with other researchers that have obtained approval from the institutional review board (IRB). After a request for study information is received, the principal investigator (Chad Bouton, MS) will determine whether the requested information can be shared given the authorization status of the study participants. After approval by the principal investigator, the researcher will be required to present a letter indicating IRB approval of their study and a copy of the approved protocol indicating that approval includes the receipt of information from this study. If this information is obtained, the principal investigator will provide the requested information (taking into account the authorization status of participants) to the researchers in a HIPAA-compliant manner.
Publications
Bouton CE, Shaikhouni A, Annetta NV, Bockbrader MA, Friedenberg DA, Nielson DM, Sharma G, Sederberg PB, Glenn BC, Mysiw WJ, Morgan AG, Deogaonkar M, Rezai AR. Restoring cortical control of functional movement in a human with quadriplegia. Nature. 2016 May 12;533(7602):247-50. doi: 10.1038/nature17435. Epub 2016 Apr 13.
PubMed 27074513Bhagat N, King K, Ramdeo R, Stein A, Bouton C. Determining grasp selection from arm trajectories via deep learning to enable functional hand movement in tetraplegia. Bioelectron Med. 2020 Aug 25;6:17. doi: 10.1186/s42234-020-00053-5. eCollection 2020.
PubMed 32864392Ciancibello J, King K, Meghrazi MA, Padmanaban S, Levy T, Ramdeo R, Straka M, Bouton C. Closed-loop neuromuscular electrical stimulation using feedforward-feedback control and textile electrodes to regulate grasp force in quadriplegia. Bioelectron Med. 2019 Nov 1;5:19. doi: 10.1186/s42234-019-0034-y. eCollection 2019.
PubMed 32232108
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Neuromuscular Stimulation for Restoring Hand Movements
- ClinicalTrials.gov ID
- NCT03385005
- Acronym / sponsor ID
- 17-0070
- Keywords
- Physical and Rehabilitation Medicine, Transcutaneous Electrical Nerve Stimulation, Healthy Volunteer, Spinal Cord Injury, Biomedical Engineering
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of this study is to evoke functional movement in the hand of both healthy individuals and individuals diagnosed with a stable cervical spinal cord injury with non-functional movement of the fingers. 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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will involve 3-10 eligible healthy volunteers and 2-5 eligible individuals with a stable cervical spinal cord injury. The study will first enroll healthy volunteers into the study in order to determine the feasibility of evoking refined hand movements through electrical stimulation, and determine the electrical stimulation parameters and electrode spatial configurations responsible for various hand movements. After this is done, the study will proceed with the enrollment of individuals with spinal cord injuries. This enrollment process is being done to reduce the participation time required for participants with a spinal cord injury, and thus lower the likelihood of risks that are more prevalent among individuals with a spinal cord injury.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Active comparator | Device: Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.This arm consists of healthy volunteers receiving electrical stimulation of the muscles within the forearm via an investigational (not FDA approved) neuromuscular stimulator. |
| Spinal Cord Injury Participants | Active comparator | Device: Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.This arm consists of spinal cord injury participants receiving electrical stimulation of the muscles within the forearm via an investigational (not FDA approved) neuromuscular stimulator. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (43 listed)
- Individuals participating in another research study that may affect the conduct or results of this study
- Individuals having or exhibiting any of the following:
- Individuals with a substance abuse (alcoholism or other) problem
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.The study involves the administration of various electrical pulses being delivered to muscles of the forearm from a neuromuscular stimulator in order to evoke different hand and finger movements. The grip strength and evoked forces at the fingertips will also be measured using sensors. | Device | Healthy Volunteers, Spinal Cord Injury Participants |
Primary outcome
The primary outcome of the study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm, as assessed by visual inspection.
Time frame: This outcome measure will be assessed at each study session throughout the 8-week duration of the study.
The primary outcome measure will be achievable wrist and finger movements that will be visually assessed for the type and extent of motion in relation to the stimulation parameters and electrode spatial configurations. The extent of wrist, forearm, and individual finger movements will be categorized as either flexion, extension, adduction, abduction, pronation, or supination and graded as no movement, slight movement, moderate movement, or substantial movement.
The primary outcome of the study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm, as assessed by force sensors.
Time frame: This outcome measure will be assessed at each study session throughout the 8-week duration of the study.
The primary outcome measure will be achievable wrist and finger movements that will be assessed by the exerted force (measured in Newtons by force sensors on the fingers and palm) in each of the flexion, extension, adduction, abduction, pronation, or supination movements. This will provide the magnitude of the movement in relation to the stimulation parameters and electrode spatial configurations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 27074513Bouton CE, Shaikhouni A, Annetta NV, Bockbrader MA, Friedenberg DA, Nielson DM, Sharma G, Sederberg PB, Glenn BC, Mysiw WJ, Morgan AG, Deogaonkar M, Rezai AR. Restoring cortical control of functional movement in a human with quadriplegia. Nature. 2016 May 12;533(7602):247-50. doi: 10.1038/nature17435. Epub 2016 Apr 13.
- Derived from this study: PubMed 32864392Bhagat N, King K, Ramdeo R, Stein A, Bouton C. Determining grasp selection from arm trajectories via deep learning to enable functional hand movement in tetraplegia. Bioelectron Med. 2020 Aug 25;6:17. doi: 10.1186/s42234-020-00053-5. eCollection 2020.
- Derived from this study: PubMed 32232108Ciancibello J, King K, Meghrazi MA, Padmanaban S, Levy T, Ramdeo R, Straka M, Bouton C. Closed-loop neuromuscular electrical stimulation using feedforward-feedback control and textile electrodes to regulate grasp force in quadriplegia. Bioelectron Med. 2019 Nov 1;5:19. doi: 10.1186/s42234-019-0034-y. eCollection 2019.
- Restoring Cortical Control of Functional Movement in a Human with QuadriplegiaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The identifiable information collected on this study will only be shared with other researchers that have obtained approval from the institutional review board (IRB). After a request for study information is received, the principal investigator (Chad Bouton, MS) will determine whether the requested information can be shared given the authorization status of the study participants. After approval by the principal investigator, the researcher will be required to present a letter indicating IRB approval of their study and a copy of the approved protocol indicating that approval includes the receipt of information from this study. If this information is obtained, the principal investigator will provide the requested information (taking into account the authorization status of participants) to the researchers in a HIPAA-compliant manner.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad E Bouton, MS principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator. in people with Healthy Volunteers and Spinal Cord Injury Cervical, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of the study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm, as assessed by visual inspection. (time frame: This outcome measure will be assessed at each study session throughout the 8-week duration of the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03385005, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.