Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:

Transcranial Magnetic Stimulation of the Pre-Frontal Cortex in the Treatment of Attention Deficit/Hyperactivity Disorders: A Randomized, Controlled, Double Blind Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01618110
• Other study ID #: SH-12-0012
• Status: Not yet recruiting
• Phase: N/A
• First received: June 10, 2012
• Last updated: June 18, 2012
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: June 2012
• Source: Shalvata Mental Health Center
• Contact: Aviv Segev, MD
• Phone: 972-9-7478-644
• Email: aviv.segev[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 18-50

• Established diagnosis of ADHD

• No C/I for TMS

• Has signed an informed consent form

Exclusion Criteria:

• Major Psychiatric disorders (Psychotic or Affective)

• Active use of drugs (4 weeks prior to participation)

• Neurologic disorder such as Epilepsy.

• No use of stimulants during the previous 7 days

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Other:
• Placebo Treatment
Sham coil (minimal magnetic field, same noise and feeling)

Locations

Country	Name	City	State
Israel	Shalvata MHC	Hod Hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel,