A Double Blind Randomized Controlled Evaluation of the HBLPADD-coil Transcranial Magnetic Stimulation (TMS) Device - Efficacy and Safety In Subjects With ADHD.

November 5, 2012 updated by: Shalvata Mental Health Center

Objectives:The purpose of the study is to explore the efficacy and safety of HBLPADD Coil deep brain TMS in subjects with ADHD.

Patient Population: The intention is to treat 40 patients diagnosed with ADHD. The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age.

Structure: The study is a randomized, prospective, 5 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated.

The study group will receive active dTMS treatment and the control group will receive an inactive, sham treatment

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hod hasharon, Israel
        • Shalvata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients between the ages of 18-65(male and female).
  2. Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV.
  3. Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments.
  4. Gave informed consent for participation in the study.
  5. If referred by the treating psychiatrist, he or she approves of the subjects participation in the study.

Exclusion Criteria:

  1. Suffering from other diagnosis on axis 1.
  2. antipsychotic treatment with stabilizers; medications from the Benzodiazepines group are allowed, if need be,to a maximum dosage of 2 mg lorazepam.
  3. History of lack of tolerance to TMS.
  4. Axis 2 diagnosis according to the DSM IV.
  5. Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.
  6. Attempted suicide in the past year.
  7. High and not controlled blood pressure.
  8. History of epilepsy, seizure, or hot spasm.
  9. History of epilepsy or seizure in first degree relatives.
  10. History of a significant head injury
  11. History of metal in the head (outside the mouth space).
  12. Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
  13. Use of hearing aids for hearing loss.
  14. History of frequent or severe headaches.
  15. History of drug or alcohol abuse during the last year.
  16. Inability to achieve satisfying level of communication with the subject.
  17. Participation in current clinical study or clinical study within 30 days prior to this study
  18. Patients declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
  19. Women - Pregnancy or not using a reliable method of birth control.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
deep TMS treatment
Device: HBLPADD coil deep TMS
20 daily deep TMS treatment
SHAM_COMPARATOR: 2
inactive treatment
Device: Sham
inactive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group.
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical improvement as measured using Clinical global Impression (CGI).
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shalvata Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ANTICIPATED)

May 1, 2013

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (ESTIMATE)

November 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SH-0025-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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