Open Label Study for the Use of Transcranial Ultrasound Treatment of Tremor

Last updated: January 25, 2023
Sponsor: Neurological Associates of West Los Angeles
Overall Status: Active - Recruiting

Phase

1

Condition

Essential Tremor

Dystonia

Treatment

N/A

Clinical Study ID

NCT05475340
fUS-Tremor
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thisstudy, 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

Exclusion Criteria: In order for a subject to be considered for this study, he/she may NOT have any of thefollowing: 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 environmentsufficiently 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 birthcontrol method Males not willing to use a double-barrier birth control method with female sex partnerswith 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 ofsquamous cell cancer)

Study Design

Total Participants: 50
Study Start date:
July 13, 2022
Estimated Completion Date:
August 13, 2024

Study Description

This study is designed to evaluate the safety and efficacy of focused ultrasound in patients with Parkinson's Disease or Essential Tremor characterized by tremor. The safety of this protocol will be closely monitored and data will be used to determine whether any significant safety issues exist when using focused ultrasound. Adverse events will be noted whenever they occur but will be recorded at the time of the procedure and throughout routine follow-ups, which will persist weekly throughout the duration of the active study protocol. Patients deemed potentially appropriate candidates for focused ultrasound therapy will be treated with 8 sessions of transcranial ultrasound, each of which consists of 10 to 30 minutes of active administration. Clinical and safety outcome measures will be obtained throughout and after completion of the study protocol.

Connect with a study center

  • Neurological Associates of West Los Angeles

    Los Angeles, California 90403
    United States

    Active - Recruiting

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