The Use of Transcranial Focused Ultrasound for the Treatment of Neurodegenerative Dementias

NCT04250376 | Unknown FDA Device

• 1 other identifier: 32222-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Mild Dementia; Parkinson Disease; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Quick Dementia Rating Scale

  The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia).

  Baseline

Secondary Outcomes (5)

• Repeatable Battery Assessment for Neuropsychological Status (RBANS)

  Baseline

• Repeatable Battery Assessment for Neuropsychological Status (RBANS)

  After final ultrasound (8 weeks from baseline)

• Montreal Cognitive Assessment (MoCA)

  Baseline

• Montreal Cognitive Assessment (MoCA)

  After final ultrasound (8 weeks from baseline)

• Quick Dementia Rating Scale (QDRS)

  After final ultrasound (8 weeks from baseline)

Study Arms (1)

Treatment

EXPERIMENTAL

All patients enrolled will receive transcranial focused ultrasound. Target location is dependent on patient condition.

Device: Focused Transcranial Ultrasound

Interventions

Focused Transcranial Ultrasound DEVICE

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).

Treatment

Eligibility Criteria

• Age: 45 Years - 93 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead

Study Sites (1)

Neurological Associates of West LA

Santa Monica, California, 90403, United States

Location

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MeSH Terms

Conditions

Cognitive Dysfunction; Parkinson Disease; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Tauopathies

Study Officials

• Sheldon E Jordan, M.D.

  Neurology Management Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: November 27, 2017
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)