Influence of Transcutaneous Spinal Stimulation Intensity on Spasticity After SCI

NCT04243044 | Completed FDA Device

• 1 other identifier: 1343378
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (6)

• Change in Ankle Clonus Test

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

• Change in posterior root muscle reflexes (PRMRs)

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

• Change in Plantar Flexor Reflex Response

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

• Stimulation Tolerability Questionnaire

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

• Qualities of Spasticity Survey

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

Other Outcomes (1)

• Modified SCI-SET

  Completed during the enrollment session only.

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

Transcutaneous spinal stimulation DEVICE

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.

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)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead

Study Sites (1)

Shepherd Center, Inc.

Atlanta, Georgia, 30309, United States

Location

Related Publications (1)

• Thatcher KL, Nielsen KE, Sandler EB, Daliet OJ 4th, Iddings JA, Field-Fote EC. Optimizing transcutaneous spinal stimulation: excitability of evoked spinal reflexes is dependent on electrode montage. J Neuroeng Rehabil. 2025 Jan 6;22(1):2. doi: 10.1186/s12984-024-01524-5.

  PMID: 39762915 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Edelle C Field-Fote, PT, PhD

  Shepherd Center, Atlanta GA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Spinal Injury Research & The Hulse Spinal Injury Laboratory

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 27, 2020
• Study Start: April 8, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)