- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00284219
High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ramat Gan, Israel, 52621
- Sheba medical center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:Smoking over 20 Cig a day -
Exclusion Criteria:epilepsy, psychiatry history
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Real high frequency rTMS
The patients will undergo a series of treatments of high frequency rTMS
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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.
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Sham-komparator: Sham high frequency rTMS
The patients will receive a series of sham treatments.
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Sham stimulation will be given at the same location as the active, with special sham coil.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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number of cigarettes smoked
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Revital A Amiaz, MD, Sheba medical center
- Studieleder: Abraham Zangen, Phd, Weizmann Institute of Science
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- SHEBA-04-3401-RA-CTIL
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