Clinical trial NCT05475340: Open Label Study for the Use of Transcranial Ultrasound Treatment of Tremor
Official title: Open Label Study for the Use of Transcranial Ultrasound Treatment of Tremor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Tremor
Parkinson Disease
Essential Tremor
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Essential Tremor Rating Assessment Scale (TETRAS)
timeFrame: Baseline
measure: Essential Tremor Rating Assessment Scale (TETRAS)
timeFrame: Through Completion of Study (Average time 8-weeks)
Secondary outcomes:
measure: 9 Hole Pegboard Task (9 HPT)
timeFrame: Baseline
measure: 9 Hole Pegboard Task (9 HPT)
timeFrame: Through Completion of Study (Average time 8-weeks)
measure: Parkinson's Activities of Daily Living Scale (PAD-L)
timeFrame: Baseline
measure: Parkinson's Activities of Daily Living Scale (PAD-L)
timeFrame: Through Completion of Study (Average time 8-weeks)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Neurological Associates of West Los Angeles
state: California
Study officials:
affiliation: The Regenesis Project
name: Sheldon Jordan, MD
role: PRINCIPAL_INVESTIGATOR
References: