Focused Ultrasound for the Treatment of ADHD Symptoms

NCT04497363 | Enrolling By Invitation FDA Device

• 1 other identifier: fUS_ADHD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with attention deficit hyperactive disorder (ADHD).

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Adult ADHD Self-Report Scale (ASRS-v1.1)

  This instrument is designed to evaluate for severity of symptoms as specified in the DSM-IV-TR. The ASRS is composed of 18 questions, and uses a scale that ranges from 0-4 based on the individuals mark in either the "never, rarely, sometimes, often, very often" column for a possible total score of 72. The minimum score to qualify for study inclusion is 8 (i.e., 4 or more "symptom-positive" answers), and the maximum possible score is 72. The higher the score, the more indicative of higher severity of ADHD symptoms. Each column is used to describe the severity of the individuals symptoms based on the questions asked. Each participant is asked to make a mark within one column for each question that best describes their answer. The first 6 questions of the scale comprise Part A, which is more generally used as a screening measure. Questions 12-18 comprise Part B, which provides further identifying clues for individual symptoms.

  Baseline

Secondary Outcomes (1)

• Adult ADHD Self-Report Scale (ASRS-v1.1)

  Post Final Treatment (8 weeks from baseline)

Study Arms (1)

Focused Ultrasound

EXPERIMENTAL

On the day of the ultrasound appointment, patients will undergo ten minutes of ultrasound targeting the anterior cingulate. The DWL Doppler ultrasound device enables visual and auditory waveform confirmation of the anterior 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: Brainsonix Pulsar 1002

Interventions

Brainsonix Pulsar 1002 DEVICE

Each participant will undergo 8 consecutive weekly sessions (each session is 10 minutes long) of focused ultrasound with the Brainsonix Pulsar 1002 device.

Focused Ultrasound

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Attention Deficit Hyperactive Disorder (ADHD)
• Failure to respond to traditional symptom management (e.g. stimulants, psychoeducation, cognitive-behavior therapy, etc.)
• Score of at least 8 (4 ADHD-positive items) on the Adult ADHD Self-Report Questionnaire (ASRS-V1.1)
• At least 18 years of age

You may not qualify if:

• Subjects unable to give informed consent
• 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
• Recent surgery or dental work within 3 months of the scheduled procedure.
• Pregnancy, women who may become pregnant or are breastfeeding
• 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)
• Advanced kidney, pulmonary, cardiac or liver failure

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead

Study Sites (2)

Neurological Associates of West LA

Santa Monica, California, 90403, United States

Location

Neurological Associates of West Los Angele

Santa Monica, California, 90403, United States

Location

Related Publications (11)

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  PMID: 18704022 BACKGROUND

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  PMID: 31103523 BACKGROUND

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  PMID: 21129938 BACKGROUND

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• Materna L, Wiesner CD, Shushakova A, Trieloff J, Weber N, Engell A, Schubotz RI, Bauer J, Pedersen A, Ohrmann P. Adult patients with ADHD differ from healthy controls in implicit, but not explicit, emotion regulation. J Psychiatry Neurosci. 2019 Sep 1;44(5):340-349. doi: 10.1503/jpn.180139.

  PMID: 31025560 BACKGROUND

• Tang C, Wei Y, Zhao J, Nie J. Different Developmental Pattern of Brain Activities in ADHD: A Study of Resting-State fMRI. Dev Neurosci. 2018;40(3):246-257. doi: 10.1159/000490289. Epub 2018 Jul 13.

  PMID: 30153660 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sheldon Jordan, MD

  Neurological Associates of West Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 4, 2020
• Study Start: July 1, 2020
• Primary Completion: October 30, 2025
• Study Completion: March 2, 2026
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)