Transcranial Magnetic Stimulation in Treatment of Attenti... | NCT01618110

Studies
Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders

NCT01618110

Sponsor

Shalvata Mental Health Center

Status

Unknown status

Last Update Posted

Jun 19, 2012Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Attention Deficit/Hyperactivity Disorder

Interventions

Transcranial Magnetic Stimulation (Magstim, Rapid)
Placebo Treatment

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Jun 10, 2012

First Submission Date that Met QC Criteria

Jun 12, 2012

First Posted Date

Jun 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2012

Last Update Posted Date

Jun 19, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Active Comparator		Device: Transcranial Magnetic Stimulation (Magstim, Rapid)
Sham group	Sham Comparator	Sham TMS coil (same noise, minimal magnetic field)	Other: Placebo Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Magnetic Stimulation (Magstim, Rapid)	Device	Superficial rTMS, directed at right PFC, power of 100% of MT, 10Hz for 4 seconds, intervals of 30 seconds, 42 trains.	Treatment Group

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aviv Segev, MD	Contact	972-9-7478-644		aviv.segev@clalit.org.il
Yuval Bloch, MD	Contact	972-9-7478-510		yuvalbl@clalit.org.il

Overall Officials

Name	Affiliation	Role
Yuval Bloch, MD	Shalvata MHC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shalvata MHC		Hod HaSharon			Israel	Aviv Segev, MD

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050781	Transcranial Magnetic Stimulation
C005703	salicylhydroxamic acid

Ancestor Terms

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided