The Use of Transcranial Focused Ultrasound for the Treatment of Neurodegenerative Dementias
NCT ID: NCT04250376
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2017-11-27
2025-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
All patients enrolled will receive transcranial focused ultrasound. Target location is dependent on patient condition.
Focused Transcranial Ultrasound
The FDA has determined the power intensity limits that are safe for clinical use; the proposed equipment works within these parameters. Furthermore, monitoring sessions up to one hour as proposed in this study are routinely used in patients even with acute brain injury at 2 megaHertz without any reports of complications induced by the ultrasound device. No brain heating, cavitation or bleeding has been identified with the proposed equipment and protocol. For each individual safety can be followed by performing a selective mental status exam at each session completion (for example for hippocampal targets, there will be a delayed recall memory test).
Interventions
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Focused Transcranial Ultrasound
The FDA has determined the power intensity limits that are safe for clinical use; the proposed equipment works within these parameters. Furthermore, monitoring sessions up to one hour as proposed in this study are routinely used in patients even with acute brain injury at 2 megaHertz without any reports of complications induced by the ultrasound device. No brain heating, cavitation or bleeding has been identified with the proposed equipment and protocol. For each individual safety can be followed by performing a selective mental status exam at each session completion (for example for hippocampal targets, there will be a delayed recall memory test).
Eligibility Criteria
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Inclusion Criteria
* At least one pathognomic imaging biomarker of a neurodegenerative process.
Exclusion Criteria
* 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
45 Years
93 Years
ALL
No
Sponsors
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Neurological Associates of West Los Angeles
OTHER
Responsible Party
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Principal Investigators
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Sheldon E Jordan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Neurology Management Associates
Locations
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Neurological Associates of West LA
Santa Monica, California, United States
Countries
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References
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Other Identifiers
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32222-1
Identifier Type: -
Identifier Source: org_study_id
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