NCT01723319

Brief 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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Last Updated

November 7, 2012

Status Verified

November 1, 2012

Enrollment Period

6 months

First QC Date

November 5, 2012

Last Update Submit

November 5, 2012

Conditions

ADHD

Keywords

ADHDTMSbrain stimulationclinical improvement

Outcome Measures

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.

    5 weeks

Secondary Outcomes (1)

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

    5 weeks

Study Arms (2)

1

EXPERIMENTAL

deep TMS treatment

Device: HBLPADD coil deep TMS

2

SHAM COMPARATOR

inactive treatment

Device: Sham

Interventions

HBLPADD coil deep TMSDEVICE

20 daily deep TMS treatment

1
ShamDEVICE

inactive treatment

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Suffering from other diagnosis on axis 1.
  • antipsychotic treatment with stabilizers; medications from the Benzodiazepines group are allowed, if need be,to a maximum dosage of 2 mg lorazepam.
  • History of lack of tolerance to TMS.
  • Axis 2 diagnosis according to the DSM IV.
  • Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.
  • Attempted suicide in the past year.
  • High and not controlled blood pressure.
  • History of epilepsy, seizure, or hot spasm.
  • History of epilepsy or seizure in first degree relatives.
  • History of a significant head injury
  • History of metal in the head (outside the mouth space).
  • Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
  • Use of hearing aids for hearing loss.
  • History of frequent or severe headaches.
  • History of drug or alcohol abuse during the last year.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • yechiel levkovitz, MD

    Shalvata Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yechiel Levkovitz, MD

CONTACT

972-9-7478644ylevk@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 7, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2013

Last Updated

November 7, 2012

Record last verified: 2012-11

Locations

IL(1)