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Cerebellar rTMS for the Treatment of Schizophrenic Patients

28. april 2017 opdateret af: Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center

Safety and Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia

The primary aim of this protocol is to determine whether the use of repetitive transcranial magnetic stimulation (rTMS) over vermis of the cerebellum may be safe and therapeutically effective in patients with schizophrenia. Because this is the first evaluation of this treatment in this population, the focus of this study is safety.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

8

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
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age between 18-65 years
  2. Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)

Exclusion Criteria:

  1. Prior neurosurgical procedures
  2. Any history of seizure
  3. Previous head injury

  4. Contraindication to TMS:

    1. Implanted pacemaker
    2. Medication pump
    3. Vagal stimulator
    4. Deep brain stimulator
    5. Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
    6. Signs of increased intracranial pressure
  5. TENS unit and ventriculo-peritoneal shunt
  6. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
  7. Advanced liver, kidney, cardiac, or pulmonary disease as defined clinically or a terminal medical diagnosis consistent with survival < 1 year
  8. A history of significant alcohol or drug abuse in the prior six months
  9. No focal cortical insult can be present, including tumor or vascular malformation
  10. Patients may not be actively enrolled in a separate intervention study

  11. Patients unable to undergo a brain MR:

    a. claustrophobia refractory to anxiolytics ferromagnetic metal in the body such as a prosthetic heart valve, a pacemaker, or a brain aneurysm clip).

  12. Change in antipsychotic medication during the last 4 weeks
  13. Any emergency psychiatry department visit during the last 4 weeks
  14. Been an inpatient in a psychiatry clinic within the last month
  15. Any other axis I diagnosis

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Safety of rTMS in schizophrenia patients
Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days
Enhed: Transcranial magnetic stimulation via MagPro x100 device

Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.

Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse Events
Tidsramme: 3 weeks
Adverse event collection at baseline, daily for 5 days during treatment, every other day by phone until the final assessment at week 1 follow up visit.
3 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Tidsramme: Baseline, 5 days (post-treatment), 1 week post treatment
Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.
Baseline, 5 days (post-treatment), 1 week post treatment
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale
Tidsramme: Baseline, 5 days (post-treatment), 1 week post treatment
Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.
Baseline, 5 days (post-treatment), 1 week post treatment
Positive and Negative Syndrome Scale (PANSS) - General Subscale
Tidsramme: Baseline, 5 days (post-treatment), 1 week post treatment
Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.
Baseline, 5 days (post-treatment), 1 week post treatment

Samarbejdspartnere og efterforskere

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

Sponsor

Beth Israel Deaconess Medical Center

Efterforskere

  • Ledende efterforsker: Alvaro Pascual-Leone, MD, PhD, Beth Israel Deaconess Medical Center

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

1. februar 2008

Primær færdiggørelse (Faktiske)

1. april 2009

Studieafslutning (Faktiske)

1. april 2009

Datoer for studieregistrering

Først indsendt

19. februar 2010

Først indsendt, der opfyldte QC-kriterier

19. februar 2010

Først opslået (Skøn)

22. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2007P000395

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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