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Evaluation of the Effect of rTMS on Attention in Adults Diagnosed With Attention-Deficit Hyperactivity Disorder (ADHD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Shalvata Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT00825708
First received: January 19, 2009
Last updated: January 20, 2009
Last verified: January 2009
History of Changes
  Purpose

The aim of the study is to evaluate the immediate effect of rTMS on attention in adults diagnosed with ADHD. the design is a double blind sham controlled crossover study.


Condition Intervention
Attention Deficit Hyperactivity Disorder
 Device: rTMS
Device: shamTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Evaluation of the Effect of rTMS on Attention in Adults Diagnosed With ADHD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • PANNAS questionnaire modified for attention [ Time Frame: within one hour of the rTMS session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the CANTAB neurocognitive battery [ Time Frame: within 2 hours of the stimulation ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2007
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rTMS
rTMS session
 Device: rTMS
42 2 sec trains of 20HZ rTMS in 100% MT
Sham Comparator: SHAM
sham session
 Device: shamTMS
sham TMS session

Detailed Description:

The subjects were randomly assigned to two groups. group 1 starts with the real rTMS session followed within one week with a sham session. group 2 starts with a sham session and within one week recieve a real session. the subjects go through a neurocognitive evaluation before and after rTMS sessions and a clinical evaluation questionnaire modified for attention.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-65
  • diagnosis of ADHD according to DSM IV criteria

Exclusion Criteria:

  • other axis I diagnosis
  • risk factors for seizure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825708

Contacts
Contact: Eiran V Harel, MD 097478644 evharel@clalit.org.il

Locations
Israel
Shalvata MHC, cognitive and emotion lab Recruiting
Hod Hasharon, Israel
Principal Investigator: Yuval Bloch, MD            
Sponsors and Collaborators
Shalvata Mental Health Center
  More Information

No publications provided by Shalvata Mental Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yuval Bloch, shalvataMHC
ClinicalTrials.gov Identifier: NCT00825708     History of Changes
Other Study ID Numbers: SH20107, SH20107
Study First Received: January 19, 2009
Last Updated: January 20, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:
ADHD

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 May 23, 2013