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TMS-fMRI for Neural Pathway in Smokers

21. juli 2022 opdateret af: Xingbao Li

Repetitive TMS Modulates Dorsal Lateral Prefrontal-Ventral Medial Prefrontal Pathway to Decrease Craving in Smokers

Cigarette smoking causes significant morbidity and mortality in the United States. Smoking cessation is difficult, with the average smoker attempting to quit five times before permanent success. Moreover, the majority of smoking quit attempts result in relapse. Brain stimulation for smoke cessation is an exciting new area that builds on advancing neuroscience knowledge concerning the functional neurocircuitry of addiction. Cortical stimulation can now be performed non-invasively by transcranial magnetic stimulation (TMS). Several studies have shown that TMS can reduce cue-elicited craving in smokers. Previous research by group has shown that a single session of 15 minutes high frequency (10 Hz) repetitive TMS (rTMS) at 100% motor threshold over the left dorsal lateral prefrontal cortex (DLPFC) can reduce cue-induced craving compared to sham TMS. However, the mechanism by which craving is reduced by rTMS is poorly understood both at behavioral and neural levels. Neuroimaging studies in nicotine dependence have revealed cue-related responses in numerous brain areas, including frontal, parietal cortices and subcortical areas. Recently functional magnetic resonance imaging (fMRI) studies by the group have shown that cue-induced craving induced brain activation in ventral medial prefrontal cortex (VMPFC), including medial frontal, orbital frontal and anterior cingulate. This Chair Research Development Fund (CRDF) pilot proposal will integrate two new techniques- TMS and fMRI to investigate DLPFC-VMPFC pathway in smokers. Using double-masked methods investigators hypothesize that cue-induced exposure will induce brain activity in VMPFC, and 15 minutes rTMS over DLPFC will reduce cue-induced craving through modulating DLPFC-VMPFC pathway (increased activity DLPFC and decreased activity VMPFC).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

11

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level > 10 ppm indicative of recent smoking.
  • Not received substance abuse treatment within the previous 30 days.
  • Meet criteria for nicotine dependence as determined by the FTND.
  • Be in stable mental and physical health.
  • If female, test non-pregnant and use adequate birth control.
  • No evidence of focal or diffuse brain lesion on MRI.
  • Be willing to provide informed consent.
  • Be able to comply with protocol requirements and likely to complete all study procedures.

Exclusion Criteria:

  • Current dependence, defined by DSM-V criteria, on any psychoactive substances other than nicotine or caffeine.
  • Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
  • Contraindication to rTMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for > 15 minutes, implanted electronic device, metal in the head, or pregnancy).
  • History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
  • History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
  • Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea.
  • Life time history of major Axis I disorders such as: Bipolar Affective disorder (BPAD), Schizophrenia, Post-traumatic Stress disorder (PTSD) or Dementia or Major Depression.
  • Self report of >21 standard alcohol drinks per week in any week in the 30 days prior to screening.
  • Other forms of nicotine delivery, such as nicotine patch, electronic cigarettes

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Sham-komparator: Sham rTMS
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Enhed: Transkraniel magnetisk stimulering
Andre navne:
  • TMS
Aktiv komparator: Active rTMS
Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% rMT, Total 60 trains, 15 minutes, Total pulses 3000.
Enhed: Transkraniel magnetisk stimulering
Andre navne:
  • TMS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in fMRI Neural Activation Patterns
Tidsramme: 7 days
During MRI scan in which participants will watch smoking picture, investigators will measure the change in neural activity in reward neural circuit. Whole brain imaging analysis and network analysis will be performed.
7 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction of Smoking Cue Craving
Tidsramme: pre-TMS and post-TMS approx, 30 minutes.
visual analog scale for cue craving. Participants will be asked ' Right now, I would rate the amount of my craving to smoke as:'. The minimum score is 0, and the Maximum score is 7. There are 10 items. The total minimum score is 0, and the total maximum score is 70. A higher score is more craving to smoke a cigarette. The fewer values are considered to be a better outcome.
pre-TMS and post-TMS approx, 30 minutes.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xingbao Li

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. april 2014

Primær færdiggørelse (Faktiske)

16. juni 2015

Studieafslutning (Faktiske)

16. juni 2015

Datoer for studieregistrering

Først indsendt

21. januar 2016

Først indsendt, der opfyldte QC-kriterier

26. januar 2016

Først opslået (Skøn)

27. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00032649

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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