Back to resultsOpen Label Study for the Use of Transcranial Ultrasound Treatment of Tremor
Primary Purpose
Tremor, Parkinson Disease, Essential Tremor
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Focused Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Tremor
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)
Sites / Locations
- Neurological Associates of West Los AngelesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
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.
Outcomes
Primary Outcome Measures
Essential Tremor Rating Assessment Scale (TETRAS)
The Essential Tremor Rating Assessment Scale was developed by the Tremor Research Group to quantify essential tremor severity and its impact on activities of daily living.
The ADL section of TETRAS has 12 items, each rated 0, 1, 2, 3 or 4. The maximum total score is 48. Item 1 addresses speech; item 10 addresses occupational impairment; and item 12 assesses social impact. The other 9 items assess activities that are affected primarily by upperweighting of lower limb tremor in the total performance score.
Essential Tremor Rating Assessment Scale (TETRAS)
The Essential Tremor Rating Assessment Scale was developed by the Tremor Research Group to quantify essential tremor severity and its impact on activities of daily living.
The ADL section of TETRAS has 12 items, each rated 0, 1, 2, 3 or 4. The maximum total score is 48. Item 1 addresses speech; item 10 addresses occupational impairment; and item 12 assesses social impact. The other 9 items assess activities that are affected primarily by upperweighting of lower limb tremor in the total performance score.
Secondary Outcome Measures
9 Hole Pegboard Task (9 HPT)
A validated assessment for fine motor skills, the 9-HPT involves having a participant move 9 pegs individually from starting position to 9 separate peg-holes, as quickly as possible, and to immediately return the 9 pegs to the starting position upon filling the final peg-hole. This is performed separately for each hand. The score is the time (seconds/milliseconds) that it takes to complete the task, recorded separately for dominant and non-dominant hands. The minimum detectable change is 2.6 seconds for the dominant hand and 1.3 seconds for the non-dominant hand.
9 Hole Pegboard Task (9 HPT)
A validated assessment for fine motor skills, the 9-HPT involves having a participant move 9 pegs individually from starting position to 9 separate peg-holes, as quickly as possible, and to immediately return the 9 pegs to the starting position upon filling the final peg-hole. This is performed separately for each hand. The score is the time (seconds/milliseconds) that it takes to complete the task, recorded separately for dominant and non-dominant hands. The minimum detectable change is 2.6 seconds for the dominant hand and 1.3 seconds for the non-dominant hand.
Parkinson's Activities of Daily Living Scale (PAD-L)
The Parkinson's Activities of Daily Living Scale is a self-report activities of daily living scale designed to assess difficulties in daily activities due to symptoms of Parkinson's Disease.
Parkinson's Activities of Daily Living Scale (PAD-L)
The Parkinson's Activities of Daily Living Scale is a self-report activities of daily living scale designed to assess difficulties in daily activities due to symptoms of Parkinson's Disease.
Full Information
NCT ID
NCT05475340
First Posted
July 21, 2022
Last Updated
January 25, 2023
Sponsor
Neurological Associates of West Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT05475340
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
July 13, 2024 (Anticipated)
Study Completion Date
August 13, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurological Associates of West Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tremor, Parkinson Disease, Essential Tremor
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Focused Ultrasound
Intervention Description
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 Information:
Title
Essential Tremor Rating Assessment Scale (TETRAS)
Description
The Essential Tremor Rating Assessment Scale was developed by the Tremor Research Group to quantify essential tremor severity and its impact on activities of daily living.
The ADL section of TETRAS has 12 items, each rated 0, 1, 2, 3 or 4. The maximum total score is 48. Item 1 addresses speech; item 10 addresses occupational impairment; and item 12 assesses social impact. The other 9 items assess activities that are affected primarily by upperweighting of lower limb tremor in the total performance score.
Time Frame
Baseline
Title
Essential Tremor Rating Assessment Scale (TETRAS)
Description
The Essential Tremor Rating Assessment Scale was developed by the Tremor Research Group to quantify essential tremor severity and its impact on activities of daily living.
The ADL section of TETRAS has 12 items, each rated 0, 1, 2, 3 or 4. The maximum total score is 48. Item 1 addresses speech; item 10 addresses occupational impairment; and item 12 assesses social impact. The other 9 items assess activities that are affected primarily by upperweighting of lower limb tremor in the total performance score.
Time Frame
Through Completion of Study (Average time 8-weeks)
Secondary Outcome Measure Information:
Title
9 Hole Pegboard Task (9 HPT)
Description
A validated assessment for fine motor skills, the 9-HPT involves having a participant move 9 pegs individually from starting position to 9 separate peg-holes, as quickly as possible, and to immediately return the 9 pegs to the starting position upon filling the final peg-hole. This is performed separately for each hand. The score is the time (seconds/milliseconds) that it takes to complete the task, recorded separately for dominant and non-dominant hands. The minimum detectable change is 2.6 seconds for the dominant hand and 1.3 seconds for the non-dominant hand.
Time Frame
Baseline
Title
9 Hole Pegboard Task (9 HPT)
Description
A validated assessment for fine motor skills, the 9-HPT involves having a participant move 9 pegs individually from starting position to 9 separate peg-holes, as quickly as possible, and to immediately return the 9 pegs to the starting position upon filling the final peg-hole. This is performed separately for each hand. The score is the time (seconds/milliseconds) that it takes to complete the task, recorded separately for dominant and non-dominant hands. The minimum detectable change is 2.6 seconds for the dominant hand and 1.3 seconds for the non-dominant hand.
Time Frame
Through Completion of Study (Average time 8-weeks)
Title
Parkinson's Activities of Daily Living Scale (PAD-L)
Description
The Parkinson's Activities of Daily Living Scale is a self-report activities of daily living scale designed to assess difficulties in daily activities due to symptoms of Parkinson's Disease.
Time Frame
Baseline
Title
Parkinson's Activities of Daily Living Scale (PAD-L)
Description
The Parkinson's Activities of Daily Living Scale is a self-report activities of daily living scale designed to assess difficulties in daily activities due to symptoms of Parkinson's Disease.
Time Frame
Through Completion of Study (Average time 8-weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rama Surya
Phone
3108295968
Ext
214
Email
jsurya@theneuroassociates.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jon Haroon
Phone
3108295968
Ext
214
Email
jharoon@theneuroassociates.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheldon Jordan, MD
Organizational Affiliation
The Regenesis Project
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurological Associates of West Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Haroon
Phone
310-829-5968
Ext
214
Email
jharoon@theneuroassociates.com
First Name & Middle Initial & Last Name & Degree
Kennedy Mahdavi
Phone
3108295968
Ext
214
Email
kmahdavi@theneuroassociates.com
First Name & Middle Initial & Last Name & Degree
Sheldon Jordan, MD
12. IPD Sharing Statement
Learn more about this trial
Open Label Study for the Use of Transcranial Ultrasound Treatment of Tremor
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