- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06116838
Transcutaneous Spinal Cord Stimulation in Healthy Adults
November 20, 2023 updated by: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
Effect of Varying Transcutaneous Spinal Cord Stimulation Parameters and Location on Lower Extremity Motor Responses and Comfort
The goal of this study is to understand how transcutaneous spinal cord stimulation (tSCS) waveform, modulation frequency, and stimulation location impact lower extremity muscle activation and participant comfort in adults without neurologic conditions.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Investigators will use a test-retest design comparing neurophysiologic measures while receiving various combinations of stimulation waveforms, modulation frequencies, and stimulation locations to determine the settings which lead to the highest participant tolerance with the lowest lower extremity resting motor thresholds (RMTs).
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kelly McKenzie, PT, DPT
- Phone Number: 2175210169
- Email: kmckenzie@sralab.org
Study Contact Backup
- Name: Sara Prokup, PT, DPT
- Phone Number: 312-238-1355
- Email: sprokup@sralab.org
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Shirley Ryan AbilityLab
-
Contact:
- Shreya Aalla, BS
- Phone Number: 312-238-7323
- Email: saalla@sralab.org
-
Contact:
- Kelly A McKenzie, PT, DPT
- Phone Number: 312-238-7111
- Email: kmckenzie@sralab.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age 18-75 years old
- Able and willing to give written consent and comply with study procedures
Exclusion Criteria:
- History of stroke or neurologic pathologies (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
- Pregnant or nursing
- Skin allergies or irritation; open wounds
- Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
- History of seizures or epilepsy
- Active cancer or cancer in remission less than 5 years
- Metal implants in the back or spine
- Painful musculoskeletal dysfunction due to injury or infection
- Unstable cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, uncontrolled diabetes, or chronic emphysema)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Carrier frequency + Waveform
Spinally Evoked Motor Potentials (sEMP) will be obtained while stimulating the spinal cord at a single site with single pulses.
sEMP are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord.
We will test various waveform combinations of biphasic and monophasic waveforms with modulation frequencies of 0-10 kHz.
Participants will also ambulate while receiving continuous stimulation of the various waveform combinations to determine what stimulation intensity is comfortable for each combination.
The order we complete this testing will be randomized.
All participants will perform testing in a different order.
|
Spinally Evoked Motor Responses (sMERs) will be obtained while stimulating with single pulses using various stimulation parameters.
sMERs are the electromyograph (EMG) responses of the peripheral muscles to electrical stimulation of the spinal cord.
sEMP will be used to test the integrity of the motor pathways of the spinal cord.
This will be measuring by assessing the EMG responses in the lower limb muscles.
Participants may receive up to 45 min of locomotion training (treadmill or overground training) with transcutaneous spinal cord stimulation.
The goal will be for the investigators to determine what amount of intensity at each stimulation site the individual finds to be comfortable enough that they would be able to receive without pain or discomfort
|
Experimental: Stimulation Location
Spinally Evoked Motor Potentials (sEMP) will be obtained while stimulating the spinal cord at various stimulation locations with single pulses.
sEMP are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord.
Participants will also ambulate while receiving continuous stimulation to various stimulation locations to determine what stimulation intensity is comfortable for each location.
The order we complete this testing will be randomized.
All participants will perform testing in a different order.
|
Spinally Evoked Motor Responses (sMERs) will be obtained while stimulating with single pulses using various stimulation parameters.
sMERs are the electromyograph (EMG) responses of the peripheral muscles to electrical stimulation of the spinal cord.
sEMP will be used to test the integrity of the motor pathways of the spinal cord.
This will be measuring by assessing the EMG responses in the lower limb muscles.
Participants may receive up to 45 min of locomotion training (treadmill or overground training) with transcutaneous spinal cord stimulation.
The goal will be for the investigators to determine what amount of intensity at each stimulation site the individual finds to be comfortable enough that they would be able to receive without pain or discomfort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting motor threshold
Time Frame: All study visits (1-10), over the course of up to 5 weeks
|
The RMT is the minimum intensity of stimulation required to evoke a motor response in the lower-limb muscles while the subject is at rest.
|
All study visits (1-10), over the course of up to 5 weeks
|
Continuous stimulation tolerance
Time Frame: All study visits (1-10), over the course of up to 5 weeks
|
Participants may receive up to 45 min of locomotion training (treadmill or overground training) with transcutaneous spinal cord stimulation.
Participants will report what level of stimulation intensity they consider comfortable or tolerable (rating of less than 8 out of 10 on the Rating of Perceived Discomfort scale)
|
All study visits (1-10), over the course of up to 5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arun Jayarman, PT, PhD, Shirley Ryan AbilityLab
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
October 20, 2023
First Submitted That Met QC Criteria
October 30, 2023
First Posted (Actual)
November 3, 2023
Study Record Updates
Last Update Posted (Estimated)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- STU00219704
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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