Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders

June 18, 2012 updated by: Shalvata Mental Health Center

Transcranial Magnetic Stimulation of the Pre-Frontal Cortex in the Treatment of Attention Deficit/Hyperactivity Disorders: A Randomized, Controlled, Double Blind Study.

  • ADHD is one of the most common psychiatric disorders.
  • While most of the attention is directed towards youth, 60% continue to suffer symptoms into adult life.
  • Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are non-responders.
  • Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially at right PFC.
  • It is this study hypothesis that by stimulating the right PFC by TMS, it will be possible to alleviate ADHD symptoms.
  • A 10 sessions of treatment will by applied on a randomly allocated group of patients, diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS treatment, and the second group will receive a sham treatment.
  • Improvement of objective and subjective ADHD scale will be examined.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

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 Backup

Study Locations

  • Israel
      • Hod Hasharon, Israel
        • Shalvata MHC
        • Principal Investigator:
          • Yuval Bloch, MD
        • Contact:
        • Sub-Investigator:
          • Aviv Segev, MD

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

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-50
  • Established diagnosis of ADHD
  • No C/I for TMS
  • Has signed an informed consent form

Exclusion Criteria:

  • Major Psychiatric disorders (Psychotic or Affective)
  • Active use of drugs (4 weeks prior to participation)
  • Neurologic disorder such as Epilepsy.
  • No use of stimulants during the previous 7 days

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment Group
Device: Transcranial Magnetic Stimulation (Magstim, Rapid)
Superficial rTMS, directed at right PFC, power of 100% of MT, 10Hz for 4 seconds, intervals of 30 seconds, 42 trains.
Other Names:
  • Transcranial Magnetic Stimulation
  • Magstim, Rapid
Sham Comparator: Sham group
Sham TMS coil (same noise, minimal magnetic field)
Other: Placebo Treatment
Sham coil (minimal magnetic field, same noise and feeling)
Other Names:
  • Placebo
  • Sham

Collaborators and Investigators

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

Sponsor

Shalvata Mental Health Center

Investigators

  • Principal Investigator: Yuval Bloch, MD, Shalvata MHC

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

July 1, 2012

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

June 10, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-12-0012

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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