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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Brainsway.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Brainsway
ClinicalTrials.gov Identifier:
NCT01196910
First received: September 7, 2010
Last updated: December 20, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Device: treatment by HLPFC coil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Brainsway:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196910

Contacts
Contact: Elissa Ash, Dr. +972-3-6973328 elissaa@tasmc.health.gov.il

Locations
Israel
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Sponsors and Collaborators
Brainsway
  More Information

No publications provided

Responsible Party: Dr. Elissa Ash, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01196910     History of Changes
Other Study ID Numbers: IBR-0014-00
Study First Received: September 7, 2010
Last Updated: December 20, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014