Status:
ENROLLING_BY_INVITATION
Focused Ultrasound for the Treatment of ADHD Symptoms
Lead Sponsor:
Neurological Associates of West Los Angeles
Conditions:
ADHD
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of this open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with attention deficit hyperactive disorder (ADHD).
Detailed Description
The primary cortical regions thought to be implicated in ADHD include the prefrontal, orbitofrontal, and anterior cingulate cortices. A possible treatment approach for ADHD would employ a process desi...
Eligibility Criteria
Inclusion
- Diagnosis of Attention Deficit Hyperactive Disorder (ADHD)
- Failure to respond to traditional symptom management (e.g. stimulants, psychoeducation, cognitive-behavior therapy, etc.)
- Score of at least 8 (4 ADHD-positive items) on the Adult ADHD Self-Report Questionnaire (ASRS-V1.1)
- At least 18 years of age
Exclusion
- • Subjects unable to give informed consent
- Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
- Recent surgery or dental work within 3 months of the scheduled procedure.
- Pregnancy, women who may become pregnant or are breastfeeding
- Advanced terminal illness
- Any active cancer or chemotherapy
- Any other neoplastic illness or illness characterized by neovascularity
- Macular degeneration
- Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
- Advanced kidney, pulmonary, cardiac or liver failure
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 2 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04497363
Start Date
July 1 2020
End Date
March 2 2026
Last Update
September 28 2022
Active Locations (2)
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1
Neurological Associates of West LA
Santa Monica, California, United States, 90403
2
Neurological Associates of West Los Angele
Santa Monica, California, United States, 90403