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

This study is currently recruiting participants.
Verified July 2011 by Brainsway
Sponsor:
Information provided by:
Brainsway
ClinicalTrials.gov Identifier:
NCT01196910
First received: September 7, 2010
Last updated: December 20, 2011
Last verified: July 2011

September 7, 2010
December 20, 2011
July 2011
July 2012   (final data collection date for primary outcome measure)
Conners' Adult ADHD Rating Scale [ Time Frame: Screening, at the end of three weeks of treatment, and for each of two follow-up meetings ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01196910 on ClinicalTrials.gov Archive Site
Mindstreams Cognitive Tests [ Time Frame: Screening, at the end of three weeks of treatment, and for each of two follow-up meetings ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
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 left dorsolateral prefrontal cortex
    Group A (fifteen subjects) - treatment by HLPFC coil high-frequency stimulation over the left dorsolateral prefrontal cortex (DLPFC).
    Intervention: Device: treatment by HLPFC coil
  • Active Comparator: stimulation over the right DLPFC
    Group B (fifteen subjects) - Treatment by HLPFC coil high-frequency stimulation over the right DLPFC.
    Intervention: Device: treatment by HLPFC coil
  • Placebo Comparator: Treatment with HLPFC coil simulator mode
    Group C (fifteen subjects) - Treatment with HLPFC coil simulator mode (sham).
    Intervention: Device: treatment by HLPFC coil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
July 2013
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Elissa Ash, Dr. +972-3-6973328 elissaa@tasmc.health.gov.il
Israel
 
NCT01196910
IBR-0014-00
No
Dr. Elissa Ash, Tel-Aviv Sourasky Medical Center
Brainsway
Not Provided
Not Provided
Brainsway
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP