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Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Shalvata Mental Health Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01618110
First Posted: June 13, 2012
Last Update Posted: June 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shalvata Mental Health Center
  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 (Participant, 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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01618110     History of Changes
Other Study ID Numbers: SH-12-0012
First Submitted: June 10, 2012
First Posted: June 13, 2012
Last Update Posted: June 19, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms