Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT04742257
Eligibility Criteria:
Inclusion Criteria:
* ≥ 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)
Exclusion Criteria:
* Fixed contractures or profound muscle atrophy of the target spastic wrist to be treated
* 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
* 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
* Previous participating in a study involving the application of tsDCS
* Pregnancy in women (as determined by pregnancy test in pre-menopausal women)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04742257
Study Brief:
Protocol Section:
NCT04742257