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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
  Purpose
  • 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.

Condition Intervention
Attention Deficit/Hyperactivity Disorder
 Device: Transcranial Magnetic Stimulation (Magstim, Rapid)
Other: Placebo Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation of the Pre-Frontal Cortex in the Treatment of Attention Deficit/Hyperactivity Disorders: A Randomized, Controlled, Double Blind Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shalvata Mental Health Center:

Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Magstim, Rapid
  • Transcranial Magnetic Stimulation
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

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618110

Contacts
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

Locations
Israel
Shalvata MHC Not yet recruiting
Hod Hasharon, Israel
Contact: Aviv Segev, MD     972-9-7478-644     aviv.segev@clalit.org.il    
Principal Investigator: Yuval Bloch, MD            
Sub-Investigator: Aviv Segev, MD            
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Principal Investigator: Yuval Bloch, MD Shalvata MHC
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01618110     History of Changes
Other Study ID Numbers: SH-12-0012
Study First Received: June 10, 2012
Last Updated: June 18, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:
ADHD
Attention Deficit/Hyperactivity Disorder
TMS
Transcranial Magnetic Stimulation

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 October 17, 2012