- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00825708
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
Conditions
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SH20107
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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