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Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders

Primary Purpose

Attention Deficit/Hyperactivity Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (Magstim, Rapid)
Placebo Treatment
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit/Hyperactivity Disorder focused on measuring ADHD, Attention Deficit/Hyperactivity Disorder, TMS, Transcranial Magnetic Stimulation

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shalvata MHC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Treatment Group

Sham group

Arm Description

Sham TMS coil (same noise, minimal magnetic field)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 10, 2012
Last Updated
June 18, 2012
Sponsor
Shalvata Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT01618110
Brief Title
Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder
Keywords
ADHD, Attention Deficit/Hyperactivity Disorder, TMS, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Sham TMS coil (same noise, minimal magnetic field)
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (Magstim, Rapid)
Other Intervention Name(s)
Magstim, Rapid, Transcranial Magnetic Stimulation
Intervention Description
Superficial rTMS, directed at right PFC, power of 100% of MT, 10Hz for 4 seconds, intervals of 30 seconds, 42 trains.
Intervention Type
Other
Intervention Name(s)
Placebo Treatment
Other Intervention Name(s)
Placebo, Sham
Intervention Description
Sham coil (minimal magnetic field, same noise and feeling)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aviv Segev, MD
Phone
972-9-7478-644
Email
aviv.segev@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Bloch, MD
Phone
972-9-7478-510
Email
yuvalbl@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuval Bloch, MD
Organizational Affiliation
Shalvata MHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata MHC
City
Hod Hasharon
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aviv Segev, MD
Phone
972-9-7478-644
Email
aviv.segev@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Yuval Bloch, MD
First Name & Middle Initial & Last Name & Degree
Aviv Segev, MD

12. IPD Sharing Statement

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Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders

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