Clinical trial NCT04250376: The Use of Transcranial Focused Ultrasound for the Treatment of Neurodegenerative Dementias
Official title: The Use of Transcranial Focused Ultrasound for the Treatment of Neurodegenerative Dementias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Mild Dementia
Parkinson Disease
Alzheimer Disease
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 93
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this open label study is to evaluate longer term tolerability and early efficacy of transcranial ultrasound in the treatment of patients with mild cognitive impairment or dementia.

Detailed description: The present study is designed as an open label study of patients with mild cognitive impairment (MCI) or dementia to evaluate longer term tolerability and early efficacy of transcranial ultrasound treatment.

Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures which are not affected by practice effects. For patients with amnestic predominant cognitive change, the target will be the mesial temporal lobe through a trans temporal scalp window. Targeting will include reference to scalp fiducials based on the obtained MRI and Transcranial Doppler (TCD) waveform confirmation will be obtained because of the ability of TCD to record Doppler signal from the posterior cerebral artery that runs medial to the mesial temporal lobe.

On the day of the ultrasound appointment, patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the hippocampus or the putamen and substantia nigra, depending on the predetermined condition. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space. Patients will undergo 8 total sessions of focused ultrasound. Patients will be evaluated at baseline and upon final ultrasound treatment using the same measures obtained upon entry. Safety and any adverse events will be monitored closely.

Eligibility criteria: Inclusion Criteria:

* CDR stage of at least 0.5 (mild cognitive impairment)
* At least one pathognomic imaging biomarker of a neurodegenerative process.

Exclusion Criteria:

* Cognitive decline clearly related to an acute illness
* Subjects unable to give informed consent
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
* Advanced terminal illness
* Advanced kidney, pulmonary, cardiac or liver failure
* 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
* Subjects with major depressive disorder
* Subjects with vascular causes of dementia

Primary outcomes:
measure: Quick Dementia Rating Scale
timeFrame: Baseline
Secondary outcomes:
measure: Repeatable Battery Assessment for Neuropsychological Status (RBANS)
timeFrame: Baseline
measure: Repeatable Battery Assessment for Neuropsychological Status (RBANS)
timeFrame: After final ultrasound (8 weeks from baseline)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: After final ultrasound (8 weeks from baseline)
measure: Quick Dementia Rating Scale (QDRS)
timeFrame: After final ultrasound (8 weeks from baseline)
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West LA
state: California
Study officials:
affiliation: Neurology Management Associates
name: Sheldon E Jordan, M.D.
role: PRINCIPAL_INVESTIGATOR
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