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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

Primary Purpose

Attention Deficit Disorder Patients

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation. PFC
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder Patients focused on measuring age 18-65

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65 years
  • ADD/ADHD

Exclusion Criteria:

  • any DSM-IV psychiatric disorder except ADD/ADHD
  • use of psychoactive medications
  • Epilepsy
  • brain injury

Sites / Locations

  • Ben-Gurion University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

control

Deep TMS PFC Lt

DEEP TMS PFC Rt

Superficial TMS PFC Lt

superficial TMS PFC Rt

Arm Description

control-sham

Deep TMS PFC left

DEEP TMS PFC Rt

Superficial TMS PFC Lt

superficial TMS PFC Rt

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 20, 2012
Last Updated
November 26, 2012
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01737476
Brief Title
Trial to Evaluate the Efficacy of the HLPFC Coil Deep Transcranial Magnetic Stimulation System in Treating Attention Deficit and Hyperactivity Disorder (ADHD) in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder Patients
Keywords
age 18-65

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Sham Comparator
Arm Description
control-sham
Arm Title
Deep TMS PFC Lt
Arm Type
Active Comparator
Arm Description
Deep TMS PFC left
Arm Title
DEEP TMS PFC Rt
Arm Type
Active Comparator
Arm Description
DEEP TMS PFC Rt
Arm Title
Superficial TMS PFC Lt
Arm Type
Active Comparator
Arm Description
Superficial TMS PFC Lt
Arm Title
superficial TMS PFC Rt
Arm Type
Active Comparator
Arm Description
superficial TMS PFC Rt
Intervention Type
Procedure
Intervention Name(s)
Transcranial Magnetic Stimulation. PFC
Other Intervention Name(s)
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadar Shalev, MD
Phone
97286400353
Email
shalev@bgu.ac.il
Facility Information:
Facility Name
Ben-Gurion University
City
Beer-Sheva
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadar Shalev, MD
Phone
97286400353
Email
shalev@bgu.ac.il

12. IPD Sharing Statement

Citations:
PubMed Identifier
33957168
Citation
Hadas I, Hadar A, Lazarovits A, Daskalakis ZJ, Zangen A. Right prefrontal activation predicts ADHD and its severity: A TMS-EEG study in young adults. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Dec 20;111:110340. doi: 10.1016/j.pnpbp.2021.110340. Epub 2021 May 3.
Results Reference
derived

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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

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