Focused Ultrasound for the Treatment of ADHD Symptoms

September 26, 2022 updated by: Neurological Associates of West Los Angeles

Open Label Study for the Use of Transcranial Ultrasound Treatment of Attention Deficit Hyperactive Disorder

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The primary cortical regions thought to be implicated in ADHD include the prefrontal, orbitofrontal, and anterior cingulate cortices. A possible treatment approach for ADHD would employ a process designed to promote healthier function of the anterior cingulate region. The anterior cingulate in particular appears to be implicated in the activation of cognitive control networks, and has been posited as an area of interest for therapeutic research on ADHD. The subjects in this research study will be recruited through medical practice and enrolled in an 8-week protocol to undergo 8 consecutive weekly ultrasound sessions.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Neurological Associates of West LA
      • Santa Monica, California, United States, 90403
        • Neurological Associates of West Los Angele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Focused Ultrasound
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
Each participant will undergo 8 consecutive weekly sessions (each session is 10 minutes long) of focused ultrasound with the Brainsonix Pulsar 1002 device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adult ADHD Self-Report Scale (ASRS-v1.1)
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adult ADHD Self-Report Scale (ASRS-v1.1)
Time Frame: Post Final Treatment (8 weeks from baseline)
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 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. Improvement will be gauged by reduction in overall score (minimally clinically important difference will be 20% for this study).
Post Final Treatment (8 weeks from baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurological Associates of West Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

October 30, 2025

Study Completion (Anticipated)

March 2, 2026

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • fUS_ADHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ADHD

Clinical Trials on Brainsonix Pulsar 1002

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe