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

ADHD Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01723319
• Other study ID #: SH-0025-12
• Status: Not yet recruiting
• Phase: N/A
• First received: November 5, 2012
• Last updated: November 5, 2012
• Start date: November 2012

Study information

• Verified date: November 2012
• Source: Shalvata Mental Health Center
• Contact: Yechiel Levkovitz, MD
• Phone: 972-9-7478644
• Email: ylevk[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD

Intervention

Device:
• HBLPADD coil deep TMS
20 daily deep TMS treatment
• Sham
inactive treatment

Locations

Country	Name	City	State
Israel	Shalvata	Hod hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 weeks	No
Secondary	clinical improvement as measured using Clinical global Impression (CGI).		5 weeks	No