Ultrasonic Neuromodulation for Treatment of Cognitive Impairment

Sponsor

University of Utah (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06135051

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate a new form of non-invasive deep brain therapy for individuals with Alzheimer's disease. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging, PET imaging, and numerical scales of cognitive performance.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Dementia Cognitive Impairment	Device: Diadem prototype	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Cognitive Impairment

Anticipated Study Start Date :

Apr 1, 2024

Anticipated Primary Completion Date :

Apr 1, 2027

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active stimulation Low-intensity transcranial focused ultrasound stimulation of deep brain targets affected by Alzheimer's disease.	Device: Diadem prototype The device delivers low-intensity ultrasonic waves into specific brain targets.
Sham Comparator: Sham stimulation Sham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses.	Device: Diadem prototype The device delivers low-intensity ultrasonic waves into specific brain targets.

Arm

Intervention/Treatment

Experimental: Active stimulation

Low-intensity transcranial focused ultrasound stimulation of deep brain targets affected by Alzheimer's disease.

Device: Diadem prototype

The device delivers low-intensity ultrasonic waves into specific brain targets.

Sham Comparator: Sham stimulation

Sham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses.

Device: Diadem prototype

The device delivers low-intensity ultrasonic waves into specific brain targets.

Outcome Measures

Primary Outcome Measures

Montreal Cognitive Assessment Test for Dementia (MoCA) [Up to 3 months following study initiation]
The MoCA is a 30-point test to detect cognitive impairment. Scores range from 0 (poor) and 30 (perfect).
Hamilton Depression Rating Scale (HDRS-17) [Up to 3 months following study initiation]
This 17-item questionnaire rates the severity of depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The scores range from 0 (no symptoms) to 52 (worst possible).
Amyloid PET [Up to 3 months following study initiation]
PET (positron emission tomography) combined with fluorine-18 labelled radiotracers provide brain scans that are interpreted as either amyloid-beta positive or negative.

Secondary Outcome Measures

Hopkins Verbal Learning Test-Revised (HVLT-R) [Up to 3 months following study initiation]
HVLT-R is a verbal memory test with 12 words learned over three trials, with the correct words summed for the Total Recall score (range = 0 (worst) - 36 (best)). The Delayed Recall score is the number of correct words recalled after a 20 - 25-minute delay (range = 0 (worst) - 12 (best)).
Digit Span Memory Test [Up to 3 months following study initiation]
A standard test for working memory. In this test, a list of random numbers or letters is presented on a computer screen at the rate of one per second. The test begins with three numbers, increasing until the person commits errors. The average digit span for normal adults without error is seven plus or minus two. The higher the number, the more patent the working memory.
Trail Making Test, Part A and B [Up to 3 months following study initiation]
The test probes visual scanning and working memory. The task is to connect a set of 25 dots as quickly as possible while maintaining accuracy. The faster the completion of Part A and Part B, the better.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Mild cognitive impairment or mild dementia due to Alzheimer's disase (AD) with confirmed AD biomarkers (Amyloid PET or CSF)
Age 65-80
MOCA > 18

Exclusion Criteria:

Evidence of cerebral amyloid angiopathy or stroke within 1 year
Clinical symptoms or findings suggestive of alternative diagnosis or co-pathology
Inability to complete MRI
Suicidal ideation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84108

Sponsors and Collaborators

University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jan Kubanek, Assistant Professor, University of Utah

ClinicalTrials.gov Identifier:

NCT06135051

Other Study ID Numbers:

IRB_00173042

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Cognitive Dysfunction

Study Results

No Results Posted as of Nov 18, 2023