Deep Transcranial Magnetic Stimulation (DTMS) as a Treatment for Attention Deficit Hyperactivity Disorder (ADHD) in Adults

July 13, 2020 updated by: Brainsway

Test Efficiency of Deep Transcranial Magnetic Stimulation (DTMS) Using an H-coil for Dorso-Lateral Prefrontal Cortex (HLPFC) to Treat Attention Deficit Hyperactivity Disorder (ADHD) in Adults

The aim of the study is to assess the effect of left or right high-frequency DTMS on ADHD symptoms, cognitive performance and decision-making ability of ADHD adults, and to compare this to the effect of sham DTMS on ADHD adults

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Attention deficit disorder in adults may be due to hypoactivity of prefrontal areas of the brain. Increasing the activity of these areas may help improve symptoms in many of these patients. In addition there is evidence as to dysfunction in both hemispheres of the brain, but it is difficult to determine the contribution of each hemisphere's pattern of activity to behavioral impairment. The purpose of this study is to use high-frequency DTMS to stimulate activity either on the left side of the prefrontal cortex (one arm), or on the right side (a second arm), to see if such stimulation improves attention, comparing to sham DTMS simulation (a third arm).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Recruiting
        • Tel-Aviv Sourasky Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged 18-65.

  • Appropriate diagnosis of ADHD according to DSM-IV criteria:

    o DSM-IV criteria require not only that the ADHD symptoms be present now (self-report), but also to have been present in childhood (self-report)

  • Subjects taking medications for attention deficit disorder will give their consent to stop the drugs from a week before the start of participation in the study, and during the daily treatment phase (four weeks total); subjects also will be asked not to take these medications 24 hours before participation in the review meetings (4 and 8 weeks after the end of the daily treatment phase).
  • Subjects have given their written and oral consent to participate in research.

Exclusion Criteria:

  • Any DSM-IV Axis I psychiatric disorder.
  • Use of antipsychotic stabilizers; other than benzodiazepines if necessary to a daily dosage equivalent to 2 mg Lorazepam.
  • History of lack of tolerance to TMS.
  • Diagnosis of severe DSM-IV personality disorder.
  • Current suicidal tendency.
  • Uncontrolled high blood pressure
  • History of epilepsy, seizures or fever convulsions.
  • History of epilepsy or convulsions in first-degree relatives.
  • A history of head injury or a stroke which caused deficits.
  • History of metal in the head (outside the oral cavity).
  • History of plastic or metal implants, including metallic particles in the eye, pacemaker, implanted hearing aid devices, use of neurostimulators, or any medical pump.
  • A history of drug or alcohol misuse.
  • People who lack judgment or are unable to communicate with the experimenters.
  • Participation in any other medical research during the three months prior to the time of this experiment.
  • Subject's inability to sign a consent form.
  • Pregnancy, or not using contraception.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Stimulation over the left dorsolateral prefrontal cortex
Group A (fifteen subjects) - treatment by HLPFC coil high-frequency stimulation over the left dorsolateral prefrontal cortex (DLPFC).
Device: treatment by HLPFC coil

DTMS treatment will be given for 3 weeks, 5 days a week. Before each DTMS treatment, neural network excitation practice will be done using AttenGo software (AttenGo, Herzlia, Israel).

Each treatment day: Follow-up to evaluate clinical side effects of treatment. Two additional meetings with DTMS treatment and follow-up will be held to evaluate the efficacy of treatment and side effects. The first will be four weeks after the end of the daily treatment phase; the second eight weeks after the end of the daily treatment phase.
ACTIVE_COMPARATOR: stimulation over the right DLPFC
Group B (fifteen subjects) - Treatment by HLPFC coil high-frequency stimulation over the right DLPFC.
Device: treatment by HLPFC coil

DTMS treatment will be given for 3 weeks, 5 days a week. Before each DTMS treatment, neural network excitation practice will be done using AttenGo software (AttenGo, Herzlia, Israel).

Each treatment day: Follow-up to evaluate clinical side effects of treatment. Two additional meetings with DTMS treatment and follow-up will be held to evaluate the efficacy of treatment and side effects. The first will be four weeks after the end of the daily treatment phase; the second eight weeks after the end of the daily treatment phase.
PLACEBO_COMPARATOR: Treatment with HLPFC coil simulator mode
Group C (fifteen subjects) - Treatment with HLPFC coil simulator mode (sham).
Device: treatment by HLPFC coil

DTMS treatment will be given for 3 weeks, 5 days a week. Before each DTMS treatment, neural network excitation practice will be done using AttenGo software (AttenGo, Herzlia, Israel).

Each treatment day: Follow-up to evaluate clinical side effects of treatment. Two additional meetings with DTMS treatment and follow-up will be held to evaluate the efficacy of treatment and side effects. The first will be four weeks after the end of the daily treatment phase; the second eight weeks after the end of the daily treatment phase.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Conners' Adult ADHD Rating Scale
Time Frame: Screening, at the end of three weeks of treatment, and for each of two follow-up meetings
Screening, at the end of three weeks of treatment, and for each of two follow-up meetings

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mindstreams Cognitive Tests
Time Frame: Screening, at the end of three weeks of treatment, and for each of two follow-up meetings
Screening, at the end of three weeks of treatment, and for each of two follow-up meetings

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brainsway

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IBR-0014-00

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.

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