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Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia

12. november 2021 oppdatert av: Stephan F. Taylor, University of Michigan

Functional Targeting of Transcranial Magnetic Stimulation for the Treatment of Refractory Auditory Hallucinations in Schizophrenia

Repetitive transcranial magnetic stimulation (rTMS) is a new noninvasive therapy that uses magnetic energy applied to the scalp to modulate activity in the underlying regions of the brain. In this study we will examine the efficacy of treating auditory hallucinations in schizophrenia with rTMS, comparing two methods to target stimulation to a language processing region of the brain. One method targets the stimulation site using scalp landmarks, while the other uses functional magnetic resonance imaging (fMRI) combined with a language task.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

5

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan Department of Psychiatry Depression Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Provide signed and dated informed consent form
  • Male or female, aged 18 to 60
  • Willing to comply with all study procedures and be available for the duration of the study
  • Primary diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV (29)
  • Currently reporting AHs, rated a minimum of 4 (moderate) on the auditory hallucination item of the Brief Psychiatric Rating Scale (BPRS; 27), and AH will be present daily
  • AHs must have failed to resolve after a minimum of two adequate trials (doses within standard therapeutic range for a minimum of 8 weeks each) of psychotropic medication including at least one atypical antipsychotic medication; documented trials of antipsychotic medication limited by intolerable side effects, e. g. extra-pyramidal symptoms, tardive dyskinesia, weight gain, neuroleptic-induced dysphoria, will also be considered as equivalent to adequate trials.
  • Weight and girth compatible with the bore of the MRI scanner; generally men over 6 feet tall < 250 lbs, men under 6 feet tall < 220 lbs, women over 5'11" tall < 220 lbs, or women under 5'10" tall < 200 lbs

Exclusion Criteria:

  • Substance abuse or dependence in the past 1 month
  • Current or past history of serious medical or neurological illness that could compromise brain function or present an increased risk of seizure, e. g. conditions that may significantly alter electrolyte balance, stroke, epilepsy, any history of seizure;
  • Pregnant or trying to become pregnant;
  • Inability to tolerate small, enclosed spaces without anxiety;
  • Metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles, neurostimulators, foil-backed transdermal patches;
  • Facial tattoos with metallic ink
  • Inability to follow study protocol
  • Change in antipsychotic therapy in previous 2 weeks
  • Currently under an alternative treatment order
  • Unstable symptoms which could, in the judgment of the study team, exhibit symptomatic worsening over the course of the protocol
  • Current treatment with another investigational drug or other intervention
  • Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study;
  • No quantifiable motor threshold such that TMS dosage cannot be accurately determined

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: fMRI-based targeting
Inhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions. An fMRI scan combined with a language task will be used to localize the secondary auditory cortex, followed by neuronavigation to identify the scalp location overlying the targeted cortex.
Aktiv komparator: landmark-based targeting
Inhibitory (low frequency) 1-Hz rTMS will be applied over the left temporoparietal cortex (TPC) during 10 daily 20-minute treatment sessions, with the stimulating coil located midway between the left temporal (T3) and parietal (P3) scalp landmarks, using the International 10-20 system for EEG.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Severity of Auditory Hallucinations
Tidsramme: Two weeks
Hallucination Change Scale (Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, et al. (2005): Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 58:97-104.) Baseline score, by definition: 10 Range: 0 (no hallucinations) to 20 (hallucinations twice as bad as baseline) Thus, a score of less than 10 means that hallucinations were reduced, whereas a score of greater than 10 means that hallucinations were increased.
Two weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Stephan F Taylor, M.D., University of Michigan

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2011

Primær fullføring (Faktiske)

1. august 2012

Studiet fullført (Faktiske)

1. august 2012

Datoer for studieregistrering

Først innsendt

8. mai 2012

Først innsendt som oppfylte QC-kriteriene

8. mai 2012

Først lagt ut (Anslag)

10. mai 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. desember 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. november 2021

Sist bekreftet

1. november 2021

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på rTMS with fMRI-based targeting

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