NCT00825708

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

1 year

First QC Date

January 19, 2009

Last Update Submit

January 20, 2009

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

  • PANNAS questionnaire modified for attention

    within one hour of the rTMS session

Secondary Outcomes (1)

  • the CANTAB neurocognitive battery

    within 2 hours of the stimulation

Study Arms (2)

rTMS

ACTIVE COMPARATOR

rTMS session

Device: rTMS

SHAM

SHAM COMPARATOR

sham session

Device: shamTMS

Interventions

rTMSDEVICE

42 2 sec trains of 20HZ rTMS in 100% MT

rTMS
shamTMSDEVICE

sham TMS session

SHAM

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • other axis I diagnosis
  • risk factors for seizure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata MHC, cognitive and emotion lab

Hod HaSharon, Israel

RECRUITING

Related Publications (1)

  • Bloch Y, Harel EV, Aviram S, Govezensky J, Ratzoni G, Levkovitz Y. Positive effects of repetitive transcranial magnetic stimulation on attention in ADHD Subjects: a randomized controlled pilot study. World J Biol Psychiatry. 2010 Aug;11(5):755-8. doi: 10.3109/15622975.2010.484466.

    PMID: 20521875DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Eiran V Harel, MD

CONTACT

097478644evharel@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2009

First Posted

January 21, 2009

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Last Updated

January 21, 2009

Record last verified: 2009-01

Locations

IL(1)