Recruiting
Early Phase 1

Transcranial Ultrasound

Sponsor:

Neurological Associates of West Los Angeles

Code:

NCT05475340

Conditions

Tremor

Parkinson Disease

Essential Tremor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Focused Ultrasound

Study Details

Brief summary:

The purpose of this Phase I open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with tremor as a results of Parkinson's Disease or Essential Tremor.

Conditions

Tremor

Parkinson Disease

Essential Tremor

Study ID

NCT05475340

Start date

Jul 13, 2022

Status verified date

Jan, 2023

Completion date

Aug 13, 2024

Anticipated

Primary completion date

Jul 13, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

In order for a subject to be considered for the Essential Tremor application of this study, the following criteria are required:

Subjective complaint of tremor assessed and validated by physician

Must be willing to comply with the study protocol

English Proficiency

At least 18 years of age

At most 90 years of age

In order for a subject to be considered for the Parkinson's Disease application of this study, the following criteria are required:

Diagnosis of Parkinson's Disease validated by physician

Must be willing to comply with the study protocol

English Proficiency

At least 18 years of age

At most 90 years of age

Exclusion Criteria:

In order for a subject to be considered for this study, he/she may NOT have any of the following:

Subjects not English proficient

Subjects unable to give informed consent

Subjects do not meet age requirements (18-90)

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

Pregnancy, women who may become pregnant or are breastfeeding

Women with child-bearing potential who are not willing to use a double-barrier birth control method

Males not willing to use a double-barrier birth control method with female sex partners with child-bearing potential

Advanced terminal illness

Any active cancer or chemotherapy

Any other neoplastic illness or illness characterized by neovascularity

Macular degeneration

Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental

Participants will undergo ten to thirty minutes of transcranial ultrasound treatment. The sanitation device will be aimed at the hypothalamus. 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.

Interventions

Focused Ultrasound

The DWL Doppler ultrasound device enables visual and auditory waveform confirmation of the middle cerebral artery, and optical tracking technology (e.g., AntNeuro Visor2™ system) may be used in tandem with the Brainsonix ultrasound device to track a patient's brain in virtual space as well as their physical location, thereby ensuring accurate placement.

Primary outcome measure

  • Essential Tremor Rating Assessment Scale (TETRAS) [ Time Frame: Baseline ]
  • Essential Tremor Rating Assessment Scale (TETRAS) [ Time Frame: Through Completion of Study (Average time 8-weeks) ]

Central Contacts and Locations

Locations

Neurological Associates of West Los Angeles

Recruiting

Los Angeles, California, United States, 90403

Contacts

Principal Investigator:

Sheldon Jordan, MD

More Information

Sponsor

Neurological Associates of West Los Angeles

Last update posted

Jan 26, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neurological Associates of West Los Angeles on 2023-01-26.