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

NCT05475340 | Unknown Early Phase 1 FDA Device

• 1 other identifier: fUS-Tremor
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tremor; Parkinson Disease; Essential Tremor

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Through Completion of Study (Average time 8-weeks)

Secondary Outcomes (4)

• 9 Hole Pegboard Task (9 HPT)

  Baseline

• 9 Hole Pegboard Task (9 HPT)

  Through Completion of Study (Average time 8-weeks)

• Parkinson's Activities of Daily Living Scale (PAD-L)

  Baseline

• Parkinson's Activities of Daily Living Scale (PAD-L)

  Through Completion of Study (Average time 8-weeks)

Study Arms (1)

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.

Device: Focused Ultrasound

Interventions

Focused Ultrasound DEVICE

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead

Study Sites (1)

Neurological Associates of West Los Angeles

Los Angeles, California, 90403, United States

RECRUITING

MeSH Terms

Conditions

Tremor; Parkinson Disease; Essential Tremor

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Sheldon Jordan, MD

  The Regenesis Project

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rama Surya

CONTACT

3108295968; jsurya@theneuroassociates.com

Jon Haroon

CONTACT

3108295968; jharoon@theneuroassociates.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 26, 2022
• Study Start: July 13, 2022
• Primary Completion: July 13, 2024
• Study Completion: August 13, 2024
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

US (1)