Status:
RECRUITING
Percutaneous Neurostimulation to Treat Paroxysmal Sympathetic Hyperactivity in Children
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Paroxysmal Sympathetic Hyperactivity
Eligibility:
All Genders
2-17 years
Phase:
NA
Brief Summary
Survivors of severe brain injury, such as lack of oxygen or severe traumatic brain injury, frequently experience Paroxysmal Sympathetic Hyperactivity (PSH). PSH is characterized by disabling symptoms ...
Detailed Description
Paroxysmal sympathetic hyperactivity - incidence, pathophysiology, diagnosis, treatment, prognosis and implications for treatment Paroxysmal sympathetic hyperactivity is frequently seen in survivors o...
Eligibility Criteria
Inclusion
- Children 2-17 years age with PSH due to ASBI
- PSH severity score \> 6 (moderate severity)
- Glasgow Coma Scale \< 15
Exclusion
- age \< 2 years (small ears thus less surface area to apply the leads)
- ear deformity or severe dermatitis of ear lobes,
- intractable seizures, heart block, patients with other implantable devices (cardiac pacemaker, vagal nerve stimulator, etc.
- known pregnancy
Key Trial Info
Start Date :
September 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05343988
Start Date
September 22 2022
End Date
November 30 2026
Last Update
December 5 2024
Active Locations (1)
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1
Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226