Study Evaluating MyoRegulator® Treatment in Post-Stroke Upper Limb Spasticity

Who can take part

• ≥ 18 to < 85 years of age
• First single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior to study enrollment
• At least 6 weeks of stable UE spasticity symptoms (as confirmed by medical history) with a baseline Modified Ashworth Scale (MAS) score of 1+ to 3 (on the 0, 1, 1+, 2, 3, 4 scale), inclusive, in the wrist flexor muscles
• Willing to forgo botulinum toxin, phenol or alcohol injections into the muscles of the limb targeted for the study treatment; intrathecal baclofen; digitalis, and morphine for the subject's duration in the study
• Willing to forgo upper extremity physical and occupational therapy for the duration of the study (lower extremity PT and OT are allowed)
• Willing to maintain current regiment for oral spasticity medication(s) and neurotransmitter medication(s) for the subject's duration in the study
• Cognitive function sufficient to understand the experiments and follow instructions (per interview with appropriate clinician)

Who cannot take part

• Change in antispastic oral medication (baclofen, clonidine, benzodiazepine, dantrolene, gabapentin, tizanidine) in the 2 months prior to study enrollment
• Use of digitalis, morphine, or intrathecal pump in the week prior to study enrollment
• Prior botulinum toxin injection(s) into the muscles of the limb targeted for the study treatment within 12 weeks of study enrollment
• Prior phenol or alcohol injections into the muscles of the limb targeted for the study treatment within 6 months of study enrollment
• Prior surgery for spasticity in the target muscle group
• Prior transcranial or trans-spinal direct current stimulation for any reason
• Presence of potential tsDCS risk factors:; Damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.); Lack of sensory perception at the stimulation sites; Presence of an electrically, magnetically, or mechanically activated implant (including cardiac pacemaker) or any other electrically sensitive support system with the exception of loop recorders; Ferrous metal in the path of the current flow (jewelry must be removed during stimulation); Past history of epileptic seizures or unexplained spells of loss of consciousness during the previous 36 months
• Previous participating in a study involving the application of tsDCS
• Other neurological conditions involving CNS impairment, including Parkinson's Disease, Multiple Sclerosis, and Spinal Cord Injury
• Any medical condition that would prevent the subject from being able to participate in the clinical outcome measures
• Fixed contractures or profound muscle atrophy of the target spastic wrist to be treated
• Pregnancy in women (as determined by pregnancy test in pre-menopausal women)