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Influence of Transcutaneous Spinal Stimulation Intensity on Spasticity After SCI

Primary Purpose

Spinal Cord Injuries

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcutaneous spinal stimulation

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shepherd Center, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Intensity 1 (0.8x reflex threshold, continuous, 30 minute duration)

Intensity 2 (0.8x reflex threshold, dual-site, 30 minute duration)

Intensity 3 (0.8x reflex threshold, burst, 30 minute duration)

Arm Description

Transcutaneous spinal stimulation will be applied continuously at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.

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.

Transcutaneous spinal stimulation will be applied in bursts at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.

Outcomes

Primary Outcome Measures

Change in Pendulum Test

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.

Secondary Outcome Measures

Change in Ankle Clonus Test

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.

Change in posterior root muscle reflexes (PRMRs)

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).

Change in Plantar Flexor Reflex Response

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.

Stimulation Tolerability Questionnaire

Participants will be asked to rate how tolerable stimulation was during the session and to describe specific sensations that contributed to this rating.

Qualities of Spasticity Survey

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.

Modified Penn Spasm Frequency Scale

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.

Full Information

NCT ID

NCT04243044

First Posted

January 17, 2020

Last Updated

May 18, 2023

Sponsor

Shepherd Center, Atlanta GA

1. Study Identification

Unique Protocol Identification Number

NCT04243044

Brief Title

Influence of Transcutaneous Spinal Stimulation Intensity on Spasticity After SCI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 8, 2022 (Actual)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shepherd Center, Atlanta GA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intensity 1 (0.8x reflex threshold, continuous, 30 minute duration)

Arm Type

Experimental

Arm Description

Transcutaneous spinal stimulation will be applied continuously at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.

Arm Title

Intensity 2 (0.8x reflex threshold, dual-site, 30 minute duration)

Arm Type

Experimental

Arm Description

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.

Arm Title

Intensity 3 (0.8x reflex threshold, burst, 30 minute duration)

Arm Type

Experimental

Arm Description

Transcutaneous spinal stimulation will be applied in bursts at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.

Intervention Type

Device

Intervention Name(s)

Transcutaneous spinal stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Pendulum Test

Description

Time Frame

Before and Immediately after each intervention session through study completion, an average of 2 weeks

Secondary Outcome Measure Information:

Title

Change in Ankle Clonus Test

Description

Time Frame

Before and Immediately after each intervention session through study completion, an average of 2 weeks

Title

Change in posterior root muscle reflexes (PRMRs)

Description

Time Frame

Before and Immediately after each intervention session through study completion, an average of 2 weeks

Title

Change in Plantar Flexor Reflex Response

Description

Time Frame

Before and Immediately after each intervention session through study completion, an average of 2 weeks

Title

Stimulation Tolerability Questionnaire

Description

Participants will be asked to rate how tolerable stimulation was during the session and to describe specific sensations that contributed to this rating.

Time Frame

Immediately following each intervention session through study completion, an average of 2 weeks.

Title

Qualities of Spasticity Survey

Description

Time Frame

Before and Immediately after each intervention session through study completion, an average of 2 weeks

Title

Modified Penn Spasm Frequency Scale

Description

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.

Time Frame

Before and four hours after each intervention session through study completion, an average of 2 weeks

Other Pre-specified Outcome Measures:

Title

Modified SCI-SET

Description

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.

Time Frame

Completed during the enrollment session only.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Evan Sandler, DPT

Phone

404-603-4175

evan.sandler@shepherd.org

First Name & Middle Initial & Last Name or Official Title & Degree

Kelly Thatcher, DPT

Phone

404-350-7681

kelly.thatcher@shepherd.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edelle C Field-Fote, PT, PhD

Organizational Affiliation

Shepherd Center, Atlanta GA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shepherd Center, Inc.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edelle Field-Fote, PT, PhD

Phone

404-603-4274

edelle.field-fote@Shepherd.org

First Name & Middle Initial & Last Name & Degree

Evan Sandler, PT, DPT

Phone

(404) 603-4175

evan.sandler@Shepherd.org

12. IPD Sharing Statement

Plan to Share IPD

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Influence of Transcutaneous Spinal Stimulation Intensity on Spasticity After SCI

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