Overview
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.
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
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)