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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

treatment by HLPFC coil

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tel-Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Stimulation over the left dorsolateral prefrontal cortex

stimulation over the right DLPFC

Treatment with HLPFC coil simulator mode

Arm Description

Group A (fifteen subjects) - treatment by HLPFC coil high-frequency stimulation over the left dorsolateral prefrontal cortex (DLPFC).

Group B (fifteen subjects) - Treatment by HLPFC coil high-frequency stimulation over the right DLPFC.

Group C (fifteen subjects) - Treatment with HLPFC coil simulator mode (sham).

Outcomes

Primary Outcome Measures

Conners' Adult ADHD Rating Scale

Secondary Outcome Measures

Mindstreams Cognitive Tests

Full Information

NCT ID

NCT01196910

First Posted

September 7, 2010

Last Updated

July 13, 2020

Sponsor

Brainsway

1. Study Identification

Unique Protocol Identification Number

NCT01196910

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 2011 (undefined)

Primary Completion Date

September 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brainsway

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stimulation over the left dorsolateral prefrontal cortex

Arm Type

Active Comparator

Arm Description

Group A (fifteen subjects) - treatment by HLPFC coil high-frequency stimulation over the left dorsolateral prefrontal cortex (DLPFC).

Arm Title

stimulation over the right DLPFC

Arm Type

Active Comparator

Arm Description

Group B (fifteen subjects) - Treatment by HLPFC coil high-frequency stimulation over the right DLPFC.

Arm Title

Treatment with HLPFC coil simulator mode

Arm Type

Placebo Comparator

Arm Description

Group C (fifteen subjects) - Treatment with HLPFC coil simulator mode (sham).

Intervention Type

Device

Intervention Name(s)

treatment by HLPFC coil

Intervention Description

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.

Primary Outcome Measure Information:

Title

Conners' Adult ADHD Rating Scale

Time Frame

Screening, at the end of three weeks of treatment, and for each of two follow-up meetings

Secondary Outcome Measure Information:

Title

Mindstreams Cognitive Tests

Time Frame

Screening, at the end of three weeks of treatment, and for each of two follow-up meetings

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elissa Ash, Dr.

Phone

+972-3-6973328

elissaa@tasmc.health.gov.il

Facility Information:

Facility Name

Tel-Aviv Sourasky Medical Center

City

Tel-Aviv

Country

Israel

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

34215144

Citation

Bleich-Cohen M, Gurevitch G, Carmi N, Medvedovsky M, Bregman N, Nevler N, Elman K, Ginou A, Zangen A, Ash EL. A functional magnetic resonance imaging investigation of prefrontal cortex deep transcranial magnetic stimulation efficacy in adults with attention deficit/hyperactive disorder: A double blind, randomized clinical trial. Neuroimage Clin. 2021;30:102670. doi: 10.1016/j.nicl.2021.102670. Epub 2021 Apr 18.

Results Reference

derived

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

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