High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation

NCT ID: NCT00284219

Last Updated: 2011-06-30

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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Cigarette smoking is a major public health problem causing significant morbidity and mortality. Yet, smoking cessation therapies are often ineffective at helping smokers break their addiction.

The mesolimbic dopaminergic reward system plays a crucial role in mediating the reinforcing effects of nicotine. Recently, acute high frequency repetitive transcranial magnetic stimulation (rTMS) of frontal brain regions has been shown to efficiently modulate the mesolimbic dopamine systems in both animals and humans. For this reason, we investigated whether 10 high-frequency (10Hz) rTMS treatments over the left dorsolateral prefrontal cortex can help people to withdraw smoking in comparison to placebo rTMS.

Smokers seeking to quit are recruited through newspaper advertisements. Participants were randomized to 10 days of either real or placebo high frequency rTMS.

Detailed Description

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Conditions

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Heavy Smoking

Keywords

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rTMS, smoking, dopamine, acotinine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Real high frequency rTMS

The patients will undergo a series of treatments of high frequency rTMS

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation 10Hz

Intervention Type DEVICE

3\. rTMS subjects will receive 20 trains of rTMS at a rate of 10 Hz for 6 seconds (1200 pulses/session). Pulses will be administered over the left dorsolateral prefrontal cortex, defined as 5 cm anterior and in a parasagital plane to the point of maximum stimulation of the abductor pollicis muscle. Pulse intensity will be set at 100% motor threshold.

Sham high frequency rTMS

The patients will receive a series of sham treatments.

Group Type SHAM_COMPARATOR

Magnetic stimulation using a special sham coil

Intervention Type DEVICE

Sham stimulation will be given at the same location as the active, with special sham coil.

Interventions

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Transcranial Magnetic Stimulation 10Hz

3\. rTMS subjects will receive 20 trains of rTMS at a rate of 10 Hz for 6 seconds (1200 pulses/session). Pulses will be administered over the left dorsolateral prefrontal cortex, defined as 5 cm anterior and in a parasagital plane to the point of maximum stimulation of the abductor pollicis muscle. Pulse intensity will be set at 100% motor threshold.

Intervention Type DEVICE

Magnetic stimulation using a special sham coil

Sham stimulation will be given at the same location as the active, with special sham coil.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Revital A Amiaz, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Abraham Zangen, Phd

Role: STUDY_DIRECTOR

Weizmann Institute of Science

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-04-3401-RA-CTIL

Identifier Type: -

Identifier Source: org_study_id