Influence of Transcutaneous Spinal Stimulation Intensity on Spasticity After SCI

March 5, 2024 updated by: Edelle Field-Fote, PT, PhD, Shepherd Center, Atlanta GA

Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation

Transcutaneous spinal stimulation (TSS) is a form of electrical stimulation delivered over the skin of the spine that may be valuable for reducing spasticity without the side effects of antispasticity medications. The intensity of stimulation, or dose, that promotes the best response is not known. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects of TSS as a non-drug intervention for spasticity management.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Spasticity involves involuntary muscle activity in persons with spinal cord injury (SCI) that can include increased response to muscle stretch and physical touch, as well as muscle stiffness. Due to the combination of symptoms, several drug therapies are currently prescribed to reduce spasticity but they may have negative side effects including fatigue and muscle weakness. Transcutaneous spinal stimulation (TSS) is a form of electrical stimulation delivered over the skin of the spine that seems to have effects that are similar to drug therapy. Prior studies of TSS in persons with SCI suggest that TSS can reduce spasticity without negative side effects. The intensity of stimulation, or dose, that promotes the best response is not known. In addition, sensitive measurements are necessary to assess the changes that can be seen in multiple presentations of spasticity. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects of TSS as a non-drug intervention for spasticity management.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center, Inc.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The participant must meet all of the following criteria to be eligible for the study:

  • Ability and willingness to authorize the use of protected health information (PHI)
  • Be 16 years of age or older
  • Have a SCI with any severity classification (AIS A, B, C, or D) that occurred at least 3 months ago
  • Have at least mild "spasticity" affecting lower extremity muscles, as indicated by a pendulum test first swing excursion angle of ≤ 77° or ≥ 5 beats of clonus on the ankle drop test
  • Use of prescription medications is acceptable, as long as the dosage has not changed in the last 2 weeks and notification of medication changes is made during study participation
  • Ability to follow multiple commands
  • Ability to communicate pain or discomfort

Exclusion Criteria:

The presence of any one of the following criteria leads to exclusion:

  • Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
  • Neurologic level below spinal level T12
  • History of cardiovascular irregularities (e.g. atrial fibrillation)
  • Active cancer or a history of cancer
  • Orthopedic pathology that would limit participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)
  • Use of semi-permanent or permanent anti-spasmodic treatment (i.e. botox, selective dorsal rhizotomy)
  • Women who are pregnant, or who have reason to believe they are, or may become pregnant due to unknown risks to the fetus associated with TSS
  • Persons who have implanted stimulators of any type will be excluded due to unknown potential of electrical stimulation effects (e.g. baclofen pump, epidural spinal stimulator, implanted cardiac defibrillator, diaphragmatic pacemaker)
  • Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment
  • Skin irregularities, sensitivity, or lesions that would increase the risk of stimulation-associated adverse events

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intensity 1 (0.8x reflex threshold, continuous, 30 minute duration)
Transcutaneous spinal stimulation will be applied continuously at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.
Device: Transcutaneous spinal stimulation
Transcutaneous spinal stimulation will be delivered for 30 minutes using biphasic stimulation with a single round electrode as the cathode placed directly over the spine at the T11/T12 (and the lumbar spine for dual-site stimulation) spinous interspace, and two interconnected dispersive (reference) electrodes placed on the abdomen, lateral to the umbilicus. Stimulation intensity will be set to the specified level determined through a pre-stimulation assessment (0.8x reflex threshold). Treatments will be a minimum of 48 hours apart.
Experimental: Intensity 2 (0.8x reflex threshold, dual-site, 30 minute duration)
Transcutaneous spinal stimulation will be applied continuously at two sites at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.
Device: Transcutaneous spinal stimulation
Transcutaneous spinal stimulation will be delivered for 30 minutes using biphasic stimulation with a single round electrode as the cathode placed directly over the spine at the T11/T12 (and the lumbar spine for dual-site stimulation) spinous interspace, and two interconnected dispersive (reference) electrodes placed on the abdomen, lateral to the umbilicus. Stimulation intensity will be set to the specified level determined through a pre-stimulation assessment (0.8x reflex threshold). Treatments will be a minimum of 48 hours apart.
Experimental: Intensity 3 (0.8x reflex threshold, burst, 30 minute duration)
Transcutaneous spinal stimulation will be applied in bursts at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.
Device: Transcutaneous spinal stimulation
Transcutaneous spinal stimulation will be delivered for 30 minutes using biphasic stimulation with a single round electrode as the cathode placed directly over the spine at the T11/T12 (and the lumbar spine for dual-site stimulation) spinous interspace, and two interconnected dispersive (reference) electrodes placed on the abdomen, lateral to the umbilicus. Stimulation intensity will be set to the specified level determined through a pre-stimulation assessment (0.8x reflex threshold). Treatments will be a minimum of 48 hours apart.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pendulum Test
Time Frame: Before and Immediately after each intervention session through study completion, an average of 2 weeks
The pendulum test will be performed during which the participant will be positioned supine on a mat with the lower leg hanging over the mat. A member of the study staff will support the participant's extended lower leg and then release the leg allowing it to swing freely. Muscle activity during each maneuver will be recorded using electromyography (EMG) of the quadriceps, hamstrings, tibialis anterior, and soleus muscles of the lower extremity identified as having the greatest spasticity. Biomechanical measurements will be captured through the use of an electrogoniometer placed at the knee joint.
Before and Immediately after each intervention session through study completion, an average of 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Ankle Clonus Test
Time Frame: Before and Immediately after each intervention session through study completion, an average of 2 weeks
The ankle clonus test will be performed during which the participant will be seated at the edge of a mat with the lower leg hanging over the mat. A member of the study staff will support the participant's leg above a box and then release the leg allowing the front of the foot to land on the edge of the box. Muscle activity during each maneuver will be recorded using EMG of the tibialis anterior and soleus muscles of the lower extremity identified as having the greatest spasticity. Biomechanical measurements will be captured through the use of an electrogoniometer placed at the ankle joint.
Before and Immediately after each intervention session through study completion, an average of 2 weeks
Change in posterior root muscle reflexes (PRMRs)
Time Frame: Before and Immediately after each intervention session through study completion, an average of 2 weeks
PRMRs will be assessed to identify the spinal stimulation threshold at which muscle activity occurs in the soleus (reflex threshold). Electrode placement as outlined for intervention will be followed for this assessment. Briefly, stimulating pulses of 1ms duration (applied via a Digitimer DS7A constant current stimulator) will be delivered through the stimulating electrodes and intensity will be gradually increased until a motor event is electrophysiologically observed in the soleus. This reflex threshold stimulation intensity will be utilized to set the parameters of the three tcSCS intervention sessions - 80% of reflex threshold (0.8xRT).
Before and Immediately after each intervention session through study completion, an average of 2 weeks
Change in Plantar Flexor Reflex Response
Time Frame: Before and Immediately after each intervention session through study completion, an average of 2 weeks
Muscle activity induced through noxious sensory input will be assessed through instrumented flexor reflex response. Flexor reflex response will be tested at 1.2x reflex threshold of the tibialis anterior for three stimulus trains. Then, the noxious sensory stimulus will be standardized through electrocutaneous stimulation to the plantar surface of the participant's foot (parameters: 25mA, 500Hz, 20ms train). Muscle activity after each stimulus will be recorded using electromyography (EMG) of the quadriceps, hamstrings, tibialis anterior, and soleus muscles of the lower extremity identified as having the greatest spasticity.
Before and Immediately after each intervention session through study completion, an average of 2 weeks
Stimulation Tolerability Questionnaire
Time Frame: Immediately following each intervention session through study completion, an average of 2 weeks.
Participants will be asked to rate how tolerable stimulation was during the session and to describe specific sensations that contributed to this rating.
Immediately following each intervention session through study completion, an average of 2 weeks.
Qualities of Spasticity Survey
Time Frame: Before and Immediately after each intervention session through study completion, an average of 2 weeks
The Qualities of Spasticity Survey is a self-report questionnaire that asks participants about the physical qualities of their spasticity and how it impacts daily life. Participants will be asked to report their experience with their spasticity over the past 48 hours.
Before and Immediately after each intervention session through study completion, an average of 2 weeks
Modified Penn Spasm Frequency Scale
Time Frame: Before and four hours after each intervention session through study completion, an average of 2 weeks
The Modified Penn Spasm Frequency Scale is a self-report questionnaire which asks participants to rate the frequency and severity of their spasms during the last hour.
Before and four hours after each intervention session through study completion, an average of 2 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified SCI-SET
Time Frame: Completed during the enrollment session only.
The Modified SCI-SET is a self-report questionnaire that asks participants to rate how their spasticity has impacted various aspects of their life over the past seven days.
Completed during the enrollment session only.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shepherd Center, Atlanta GA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edelle C Field-Fote, PT, PhD, Shepherd Center, Atlanta GA

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1343378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings