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Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders

This study is not yet open for participant recruitment.
Verified June 2012 by Shalvata Mental Health Center
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01618110
First received: June 10, 2012
Last updated: June 18, 2012
Last verified: June 2012
History of Changes

June 10, 2012
June 18, 2012
July 2012
July 2014   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01618110 on ClinicalTrials.gov Archive Site
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Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit/Hyperactivity Disorder
  • 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:
    • Magstim, Rapid
    • Transcranial Magnetic Stimulation
  • Other: Placebo Treatment
    Sham coil (minimal magnetic field, same noise and feeling)
    Other Names:
    • Placebo
    • Sham
  • Active Comparator: Treatment Group
    Intervention: Device: Transcranial Magnetic Stimulation (Magstim, Rapid)
  • Sham Comparator: Sham group
    Sham TMS coil (same noise, minimal magnetic field)
    Intervention: Other: Placebo Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
21 Years to 50 Years
No
Contact: Aviv Segev, MD 972-9-7478-644 aviv.segev@clalit.org.il
Contact: Yuval Bloch, MD 972-9-7478-510 yuvalbl@clalit.org.il
Israel
 
NCT01618110
SH-12-0012
No
Shalvata Mental Health Center
Shalvata Mental Health Center
Not Provided
Principal Investigator: Yuval Bloch, MD Shalvata MHC
Shalvata Mental Health Center
June 2012

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