Influence of Transcutaneous Spinal Stimulation Intensity on Spasticity After SCI

NCT ID: NCT04243044

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2023-12-01

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcutaneous spinal stimulation

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Transcutaneous spinal stimulation

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Transcutaneous spinal stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shepherd Center, Atlanta GA

OTHER

Sponsor Role: lead

Responsible Party

Edelle Field-Fote, PT, PhD

Director, Spinal Injury Research & The Hulse Spinal Injury Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edelle C Field-Fote, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shepherd Center, Atlanta GA

Locations

Shepherd Center, Inc.

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39762915 (View on PubMed)

Other Identifiers

1343378

Identifier Type: -

Identifier Source: org_study_id