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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00825708
• Other study ID #: SH20107
• Secondary ID: SH20107
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2009
• Last updated: January 20, 2009
• Start date: March 2007

Study information

• Verified date: January 2009
• Source: Shalvata Mental Health Center
• Contact: Eiran V Harel, MD
• Phone: 097478644
• Email: evharel[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65

• diagnosis of ADHD according to DSM IV criteria

Exclusion Criteria:

• other axis I diagnosis

• risk factors for seizure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Device:
• rTMS
42 2 sec trains of 20HZ rTMS in 100% MT
• shamTMS
sham TMS session

Locations

Country	Name	City	State
Israel	Shalvata MHC, cognitive and emotion lab	Hod Hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANNAS questionnaire modified for attention		within one hour of the rTMS session	No
Secondary	the CANTAB neurocognitive battery		within 2 hours of the stimulation	No