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Cerebellar rTMS for the Treatment of Schizophrenic Patients

28 april 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Interventionell

Inskrivning (Faktisk)

8

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215
        • Beth Israel Deaconess Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adverse Events
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2008

Primärt slutförande (Faktisk)

1 april 2009

Avslutad studie (Faktisk)

1 april 2009

Studieregistreringsdatum

Först inskickad

19 februari 2010

Först inskickad som uppfyllde QC-kriterierna

19 februari 2010

Första postat (Uppskatta)

22 februari 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 juni 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 april 2017

Senast verifierad

1 april 2017

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2007P000395

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Transcranial magnetic stimulation via MagPro x100 device

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