Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders
|ClinicalTrials.gov Identifier: NCT01618110|
Recruitment Status : Unknown
Verified June 2012 by Shalvata Mental Health Center.
Recruitment status was: Not yet recruiting
First Posted : June 13, 2012
Last Update Posted : June 19, 2012
- ADHD is one of the most common psychiatric disorders.
- While most of the attention is directed towards youth, 60% continue to suffer symptoms into adult life.
- Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are non-responders.
- Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially at right PFC.
- It is this study hypothesis that by stimulating the right PFC by TMS, it will be possible to alleviate ADHD symptoms.
- A 10 sessions of treatment will by applied on a randomly allocated group of patients, diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS treatment, and the second group will receive a sham treatment.
- Improvement of objective and subjective ADHD scale will be examined.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit/Hyperactivity Disorder||Device: Transcranial Magnetic Stimulation (Magstim, Rapid) Other: Placebo Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Transcranial Magnetic Stimulation of the Pre-Frontal Cortex in the Treatment of Attention Deficit/Hyperactivity Disorders: A Randomized, Controlled, Double Blind Study.|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||July 2014|
|Active Comparator: Treatment Group||
Device: Transcranial Magnetic Stimulation (Magstim, Rapid)
Superficial rTMS, directed at right PFC, power of 100% of MT, 10Hz for 4 seconds, intervals of 30 seconds, 42 trains.
Sham Comparator: Sham group
Sham TMS coil (same noise, minimal magnetic field)
Other: Placebo Treatment
Sham coil (minimal magnetic field, same noise and feeling)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618110
|Contact: Aviv Segev, MDfirstname.lastname@example.org|
|Contact: Yuval Bloch, MDemail@example.com|
|Shalvata MHC||Not yet recruiting|
|Hod Hasharon, Israel|
|Contact: Aviv Segev, MD 972-9-7478-644 firstname.lastname@example.org|
|Principal Investigator: Yuval Bloch, MD|
|Sub-Investigator: Aviv Segev, MD|
|Principal Investigator:||Yuval Bloch, MD||Shalvata MHC|