TremorEarly Phase 1NCT05475340
Open Label Study for the Use of Transcranial Ultrasound Treatment of Tremor
A Early Phase 1 study testing Focused Ultrasound in people with Tremor and Parkinson Disease, run by Neurological Associates of West Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tremor, Parkinson Disease, Essential Tremor
- What is being tested?
- Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 13 Aug 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Neurological Associates of West Los Angeles
Los Angeles, California, 90403
Jonathan Haroon, 310-829-5968 ext. 214, jharoon@theneuroassociates.com
Kennedy Mahdavi, 3108295968 ext. 214, kmahdavi@theneuroassociates.com
About this study
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.
Read the 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.
- Conditions
- Tremor, Parkinson Disease, Essential Tremor
- Being tested
- Focused Ultrasound
- Medical subject headings
- Tremor, Parkinson Disease, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused UltrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Through Completion of Study (Average time 8-weeks)
Secondary outcomes (4)
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.
Measured: Baseline
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.
Measured: Through Completion of Study (Average time 8-weeks)
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.
Measured: Baseline
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.
Measured: Through Completion of Study (Average time 8-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start13 Jul 2022
- Primary completion13 Jul 2024 (estimated)
- Study completion13 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurological Associates of West Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheldon Jordan, MD, Principal investigator, The Regenesis Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475340
- Sponsor's protocol ID
- fUS-Tremor
- Status last verified
- Jan 2023
- First submitted
- 21 Jul 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study for the Use of Transcranial Ultrasound Treatment of Tremor
- ClinicalTrials.gov ID
- NCT05475340
- Acronym / sponsor ID
- fUS-Tremor
- Conditions
- Tremor, Parkinson Disease, Essential Tremor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Neurological Associates of West Los AngelesUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 13 Jul 2024 (estimated)
- Study completion
- 13 Aug 2024 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Focused UltrasoundParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused UltrasoundThe 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. | Device | Experimental |
Primary outcome
Essential Tremor Rating Assessment Scale (TETRAS)
Time frame: Baseline
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)
Time frame: Through Completion of Study (Average time 8-weeks)
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.
4 secondary outcomes
9 Hole Pegboard Task (9 HPT)
Time frame: Baseline
9 Hole Pegboard Task (9 HPT)
Time frame: Through Completion of Study (Average time 8-weeks)
Parkinson's Activities of Daily Living Scale (PAD-L)
Time frame: Baseline
Parkinson's Activities of Daily Living Scale (PAD-L)
Time frame: Through Completion of Study (Average time 8-weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
Related trials for Tremor
RecruitingObservational study
The Encora X1™ in a Real World Observational Study
Essential Tremor
Recruiting
False Vocal Fold vs EMG Guided Botox for Vocal Tremor
Vocal Tremor
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
Not yet recruitingPhase 3
Effect of Botulinum Toxin on Resting Tremor of the Refractory Upper Limb in Parkinsonians
PARKINSON DISEASE (Disorder)
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheldon Jordan, MD principal investigator
The Regenesis Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Focused Ultrasound in people with Tremor and Parkinson Disease, run by Neurological Associates of West Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rama Surya (3108295968 ext. 214, jsurya@theneuroassociates.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Essential Tremor Rating Assessment Scale (TETRAS) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.