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

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: Unknown
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Device: treatment by HLPFC coil

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: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Conners' Adult ADHD Rating Scale	Screening, at the end of three weeks of treatment, and for each of two follow-up meetings

Secondary Outcome Measures

Outcome Measure	Time Frame
Mindstreams Cognitive Tests	Screening, at the end of three weeks of treatment, and for each of two follow-up meetings

Collaborators and Investigators

• Sponsor: Brainsway

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: September 7, 2010
• First Submitted That Met QC Criteria: September 8, 2010
• First Posted (ESTIMATE): September 9, 2010

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: IBR-0014-00