Influence of Transcutaneous Spinal Stimulation Intensity on Spasticity After SCI

Trial details

Who runs it

Shepherd Center, Atlanta GA

Trial code

NCT04243044

Record updated

7 March 2024

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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: Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord; History of cardiovascular irregularities (e.g. atrial fibrillation); Active cancer or a history of cancer; 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; The presence of any one of the following criteria leads to exclusion:; Neurologic level below spinal level T12; 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; Skin irregularities, sensitivity, or lesions that would increase the risk of stimulation-associated adverse events.

ClinicalTrials.gov NCT04243044