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Trial to Evaluate the Efficacy of the HLPFC Coil Deep Transcranial Magnetic Stimulation System in Treating Attention Deficit and Hyperactivity Disorder (ADHD) in Adults

This study is not yet open for participant recruitment.
Verified November 2012 by Soroka University Medical Center
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01737476
First received: September 20, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

The aim of the study is to investigate the efficacy of trans-cranial magnetic stimulation in treating attention deficit disorder in adults.


Condition Intervention
Attention Deficit Disorder Patients
 Procedure: Transcranial Magnetic Stimulation. PFC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: control
control-sham
 Procedure: Transcranial Magnetic Stimulation. PFC
Other Names:
  • Stimulator: Magstim rapid2. The Magstim Company Limited, Spring gardens, Whitland, Carmarthenshire, SA34 OHR, UK.
  • Coil: HLPFC. Brainsway Ltd. 19 hartum St. Bynet Building, Har Hatzofim, Jerusalem, Israel.
Active Comparator: Deep TMS PFC Lt
Deep TMS PFC left
 Procedure: Transcranial Magnetic Stimulation. PFC
Other Names:
  • Stimulator: Magstim rapid2. The Magstim Company Limited, Spring gardens, Whitland, Carmarthenshire, SA34 OHR, UK.
  • Coil: HLPFC. Brainsway Ltd. 19 hartum St. Bynet Building, Har Hatzofim, Jerusalem, Israel.
Active Comparator: DEEP TMS PFC Rt
DEEP TMS PFC Rt
 Procedure: Transcranial Magnetic Stimulation. PFC
Other Names:
  • Stimulator: Magstim rapid2. The Magstim Company Limited, Spring gardens, Whitland, Carmarthenshire, SA34 OHR, UK.
  • Coil: HLPFC. Brainsway Ltd. 19 hartum St. Bynet Building, Har Hatzofim, Jerusalem, Israel.
Active Comparator: Superficial TMS PFC Lt
Superficial TMS PFC Lt
 Procedure: Transcranial Magnetic Stimulation. PFC
Other Names:
  • Stimulator: Magstim rapid2. The Magstim Company Limited, Spring gardens, Whitland, Carmarthenshire, SA34 OHR, UK.
  • Coil: HLPFC. Brainsway Ltd. 19 hartum St. Bynet Building, Har Hatzofim, Jerusalem, Israel.
Active Comparator: superficial TMS PFC Rt
superficial TMS PFC Rt
 Procedure: Transcranial Magnetic Stimulation. PFC
Other Names:
  • Stimulator: Magstim rapid2. The Magstim Company Limited, Spring gardens, Whitland, Carmarthenshire, SA34 OHR, UK.
  • Coil: HLPFC. Brainsway Ltd. 19 hartum St. Bynet Building, Har Hatzofim, Jerusalem, Israel.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-65 years
  • ADD/ADHD

Exclusion Criteria:

  • any DSM-IV psychiatric disorder except ADD/ADHD
  • use of psychoactive medications
  • Epilepsy
  • brain injury
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737476

Contacts
Contact: Hadar Shalev, MD 97286400353 shalev@bgu.ac.il

Locations
Israel
Ben-Gurion University Not yet recruiting
Beer-Sheva, Israel
Contact: Hadar Shalev, MD     97286400353     shalev@bgu.ac.il    
Sponsors and Collaborators
Soroka University Medical Center
  More Information

No publications provided

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01737476     History of Changes
Other Study ID Numbers: sor010912ctil
Study First Received: September 20, 2012
Last Updated: November 26, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Soroka University Medical Center:
age 18-65

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013