Neuromodulation for Behavioral Changes in Neurological Disorders
ConditionDementia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorWest Virginia University
About this trial
The purpose of this study is to see if a focused ultrasound neuromodulation can be safely and effectively used to treat symptoms of emotional dysregulation such as agitation, irritability and anxiety
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 45-80 years at time of enrollment.
Diagnosis of probable mild-stage neurodegenerative dementia, including Alzheimer's disease (AD), frontotemporal dementia (FTD, including behavioral variant and language variant), or dementia with Lewy bodies (LBD), based on established consensus clinical criteria.
Presence of clinically meaningful (in treatment for or recommended for the symptoms) neuropsychiatric or behavioral symptoms including but not limited to anxiety, agitation, depression, irritability, apathy, or disinhibition
Able to undergo MRI scanning
Disqualifiers
Moderate to severe dementia (i.e., beyond mild stage).
Clinically significant MRI abnormality that may jeopardize participant safety, study conduct, or confound diagnostic assessments.
History of clinically significant neurological disorder other than the qualifying dementia diagnosis that could confound evaluation or increase risk.
Major psychiatric disorder that would interfere with participation or safety, including psychosis, active suicidal ideation, or severe mood/anxiety disorder requiring immediate intervention.
Trial design
Design model
Single group
Treatments tested in this trial
Focused Ultrasound
DeviceSubjects will undergo a single focused ultrasound Neuromodulation of the target brain region
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of Treatment Emergent Adverse Events
All adverse events that are related to FUS treatment will be assessed
Time frame
Week 12 compared to baselineSecondary outcomes
1
Change in behavioral symptoms
Change in behavioral symptoms as assessed by NPI
Time frame
Week 12 compared to baseline2
Changes in Anxiety symptoms
Changes in Anxiety symptoms as measured by GAD-7
Time frame
Week 12 compared to baselineSponsors and contacts
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Source ClinicalTrials.gov
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