Status:
COMPLETED
DDN in Stroke--COBRE
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Stroke
Spasticity, Muscle
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study team is recruiting 20 adults with spasticity due to chronic stroke for a 7 day study over 2 weeks. In people with chronic stroke, one of the most common and disabling problems is spasticity ...
Eligibility Criteria
Inclusion
- ≥18 years old
- no known neurological injuries.
- neurologically stable for \>6 months (and \>1 yr post stroke)
- medical clearance to participate
- unilateral ankle and/or wrist spasticity, confirmed by Modified Ashworth Scale (MAS) \> 1 and the presence of spastic hyperreflexia
Exclusion
- motoneuron injury (i.e. the neurons that give rise to the axons innervating the muscles) with inadequate response to stimulation
- a cardiac condition ( history of myocardial infarction, congestive heart failure, pacemaker use, coronary artery disease, atrial fibrillation, congenital heart disease, uncontrolled hypertension)
- a medically unstable condition (including temporary infections and pregnancy)
- age \<18 years old
- cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol
- metal allergies
- needle phobias
- lymphedema over a limb (due to risk of infection/cellulitis)
- abnormal bleeding tendencies
- compromised immune system
- vascular disease
- uncontrolled diabetes
- history of epilepsy (as DDN generates strong somatosensory sensation)
- anxiety disorders or in distress
- botox injection in target muscle within 3 months prior to start of study
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05196737
Start Date
March 7 2022
End Date
June 16 2023
Last Update
November 20 2024
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425