Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders

NCT ID: NCT01618110

Last Updated: 2012-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* ADHD is one of the most common psychiatric disorders.
* While most of the attention is directed towards youth, 60% continue to suffer symptoms into adult life.
* Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are non-responders.
* Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially at right PFC.
* It is this study hypothesis that by stimulating the right PFC by TMS, it will be possible to alleviate ADHD symptoms.
* A 10 sessions of treatment will by applied on a randomly allocated group of patients, diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS treatment, and the second group will receive a sham treatment.
* Improvement of objective and subjective ADHD scale will be examined.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit/Hyperactivity Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation (Magstim, Rapid)

Intervention Type DEVICE

Superficial rTMS, directed at right PFC, power of 100% of MT, 10Hz for 4 seconds, intervals of 30 seconds, 42 trains.

Sham group

Sham TMS coil (same noise, minimal magnetic field)

Group Type SHAM_COMPARATOR

Placebo Treatment

Intervention Type OTHER

Sham coil (minimal magnetic field, same noise and feeling)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial Magnetic Stimulation (Magstim, Rapid)

Superficial rTMS, directed at right PFC, power of 100% of MT, 10Hz for 4 seconds, intervals of 30 seconds, 42 trains.

Intervention Type DEVICE

Placebo Treatment

Sham coil (minimal magnetic field, same noise and feeling)

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Magstim, Rapid Transcranial Magnetic Stimulation Placebo Sham

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-50
* Established diagnosis of ADHD
* No C/I for TMS
* Has signed an informed consent form

Exclusion Criteria

* Major Psychiatric disorders (Psychotic or Affective)
* Active use of drugs (4 weeks prior to participation)
* Neurologic disorder such as Epilepsy.
* No use of stimulants during the previous 7 days
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yuval Bloch, MD

Role: PRINCIPAL_INVESTIGATOR

Shalvata MHC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shalvata MHC

Hod HaSharon, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aviv Segev, MD

Role: CONTACT

972-9-7478-644

Yuval Bloch, MD

Role: CONTACT

972-9-7478-510

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aviv Segev, MD

Role: primary

972-9-7478-644

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SH-12-0012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

rTMS in Children and Adolescents With ADHD:
NCT06389864 NOT_YET_RECRUITING NA