CClinicalTrials.gg
Status unknownNCT01723319Updated Nov 7, 2012

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

An interventional study of HBLPADD coil deep TMS and Sham in ADHD, sponsored by Shalvata Mental Health Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-11-07.

Sponsored by Shalvata Mental Health Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • ADHD

Keywords

  • ADHD
  • TMS
  • brain stimulation
  • clinical improvement
03

In context

Lead sponsor

Shalvata Mental Health Center is the lead sponsor of 73 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    1

    deep TMS treatment

    Device: HBLPADD coil deep TMS

  • Sham comparator
    2

    inactive treatment

    Device: Sham

Interventions

  • DeviceHBLPADD coil deep TMS

    20 daily deep TMS treatment

  • DeviceSham

    inactive treatment

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. clinical improvement as measured using Clinical global Impression (CGI).

    Time frame: 5 weeks

07

Study locations

1 site
  • Shalvata
    Hod hasharon, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01723319
Lead sponsor
Shalvata Mental Health Center
Responsible party
Sponsor
First posted
Nov 7, 2012
Start date
Nov 2012
Primary completion
May 2013 (estimated)
Last update
Nov 7, 2012

Study contacts

Yechiel Levkovitz, MD
Contact
ylevk@clalit.org.il
972-9-7478644
yechiel levkovitz, MD
principal investigator · Shalvata Mental Health Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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