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

January 20, 2009 updated by: Shalvata Mental Health Center

Evaluation of the Effect of rTMS on Attention in Adults Diagnosed With ADHD

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.

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Locations

      • Hod Hasharon, Israel
        • Recruiting
        • Shalvata MHC, cognitive and emotion lab
        • Principal Investigator:
          • Yuval Bloch, 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • other axis I diagnosis
  • risk factors for seizure

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: rTMS
rTMS session
42 2 sec trains of 20HZ rTMS in 100% MT
Sham Comparator: SHAM
sham session
sham TMS session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PANNAS questionnaire modified for attention
Time Frame: within one hour of the rTMS session
within one hour of the rTMS session

Secondary Outcome Measures

Outcome Measure
Time Frame
the CANTAB neurocognitive battery
Time Frame: within 2 hours of the stimulation
within 2 hours of the stimulation

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

March 1, 2007

Primary Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

January 19, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

January 1, 2009

More Information

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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