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NCT06389266Befejeződött

Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 17.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

The goal of this clinical trial is to compare two active types of transcranial magnetic stimulation in two nicotine-using populations: nicotine-using people with psychosis and nicotine-using people without a diagnosis of a psychotic disorder. The main questions it aims to answer are: 1. Can rTMS change functional connectivity in brain circuits associated with nicotine use? 2. Are those rTMS-induced changes in functional connectivity related to craving? Participants will complete tasks assessing their cognitive performance and craving before and after each week of TMS. Researchers will compare the effect of each TMS intervention on participants with and without psychosis to see if one type of TMS has an effect on nicotine craving.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
90 (tényleges)
Első benyújtás
2024. ápr. 24.
Kezdés
2023. jún. 15.
Elsődleges befejezés
2025. szept. 15.
Fő szponzor
Vanderbilt University Medical Center
Betegségek
Skizofrénia
NCT-szám
NCT06389266

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 90
  • 2023. jún. 15. és az elsődleges befejezés (2025. szept. 15.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Any devices such as pacemaker, medication pump, nerve stimulator, transcutaneous electrical nerve stimulation (TENS) unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD
  • Any changes in medications or hospitalizations within the past 90 days.

Más betegség

  • Substance use disorder (other than nicotine) within the past three months Positive urine drug screen for illicit substance use that can increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)
  • Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g. stroke, traumatic brain injury, tumor), including intracranial lesions
  • History of head trauma resulting in any loss of consciousness (>15 minutes) or neurological sequelae
  • Current history of poorly controlled headaches including chronic medication for migraine prevention
  • History of fainting spells of unknown or undetermined etiology that might constitute seizures
  • History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
  • Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
  • Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and use of central nervous system (CNS) active drugs. The published TMS guidelines review of medications to be considered with rTMS will be taken into consideration given their described effects on cortical excitability measures.

Életkor

  • All female participants of child-bearing age will be required to have a pregnancy test; any participant who is pregnant or planning to become pregnant will not be enrolled in the study

Egyéb

  • DSM-5 intellectual disability
  • Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)
  • Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit

Kiket keres a vizsgálat

  • Age between 18-65 years
  • Diagnosis of either schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria and confirmed by Structured Clinical Interview for the DSM (SCID) (First et al. 2015)
  • Current nicotine use (confirmed by expired carbon monoxide or urine cotinine)
  • Must be able to read, speak and understand English
  • Must be judged by study staff to be capable of completing the study procedures
  • Participants will be in stable outpatient psychiatric treatment and psychiatrically stable with no recent (within the past 90 days) psychiatric hospitalizations or changes in their psychiatric medication regimens.
  • All of the above except for participants will not have a diagnosis of schizophrenia or schizoaffective disorder nor a first-degree relative with a psychotic disorder.

Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Vanderbilt University Medical CenterNashvilleEgyesült ÁllamokIsmeretlen állapot

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