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SubGenual CG25 Deep Brain Stimulation in Severe Resistant Depression (CG25)

10 oktober 2018 uppdaterad av: University Hospital, Grenoble

Subgenual Cingulate Stimulation in Resistant Depression

Despite the availability of several treatments, a number of patients with major depression are refractory to therapeutical approaches and therefore suffer from chronic handicap. For these severe patients, neurosurgical therapies can be envisaged. They aim at interrupting bundles that link the orbitofrontal cortex with striatum and can therefore benefit for the patients.

This study intends to repeat Dr. Lozano's study, published in 2005 in the journal Neuron. In this study, they performed a preliminary evaluation of chronic deep brain stimulation (DBS) of the subgenual cingulate region (Brodmann area 25) to treat refractory depression as an alternative to subcaudate tractotomy. This last technique was employed in Grenoble in the 60s with satisfying results before neurosurgery for psychiatric disorders was abandoned. Since 1992, psychosurgical therapies that respect ethical recommendations have regained interest to treat highly impaired patients. Before the investigators can propose deep brain stimulation of subgenual cingulate brain region as a new therapeutic approach for the investigators patients in Grenoble, the investigators decided to reproduce their clinical evaluation on a group of 6 patients, repeating their methodology faithfully. Therefore nothing was changed to the model used by Drs. Lozano and Mayberg and the investigators took advantage of the investigators own expertise regarding deep brain stimulation and subcaudate tractotomy.

Protocol is strictly identical to the one of Mayberg and Lozano in order to confirm their preliminary results. Cartography of physiological consequences of this procedure will be assessed by measuring cerebral blood flow by PET scan (positron emission tomography). Patients will be monitored and thoroughly assessed during including psychiatric, neurological, neurosurgical, neuropsychological and PET scan exams to measure treatment efficacy and potential adverse reactions. Patients will be followed for two more years to assess medium-term complications. This study will be a first step toward further research including potentially a multicentric clinical trial.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

The protocol involves assessment of effects of CG25 (subgenual cingulate area-Brodmann 25) DBS on mood, anxiety, apathy, anhedonia, psychomotor retardation, functional state as well as safety and tolerance by specific psychometric scores.

Moreover the protocol aims at highlighting the neurocircuits modulated by CG25 DBS by means of PET (positron emission tomography) imagery

Studietyp

Observationell

Inskrivning (Faktisk)

5

Kontakter och platser

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

Studieorter

  • Frankrike
      • Grenoble, Frankrike, 38043
        • Neurosurgery department

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

30 år till 55 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

patients suffering from severe depression and referred by the psychiatry department of french University Hospital

Beskrivning

Inclusion criteria:

  • Men and women between 30 and 55 years old
  • Women at a reproductive age will have to be under successful contraceptive and will undergo a pregnancy test before inclusion
  • Patient suffering from major unipolar depression refractory to conventional therapies
  • Chronic depression with ongoing depressive episode > 12 months.
  • 4 unsuccessful therapies attempted to treat the ongoing episode, including anti-depressant monotherapies, potentialisation of antidepressant treatments, validated structured psychotherapies, electro-convulsive therapy performed accordingly to ANAES ( Agence Nationale d'Accréditation et d'Evaluation en Santé-the French Health Authority) recommendations (at least 6 sessions with bilateral technique and length control of convulsive crisis).
  • Ambulatory or hospital care
  • Able to speak French, understand study procedures and complete questionnaires.
  • Covered by french social health system
  • Living in Rhone-Alpes area without plan to move in the next 2 years

Exclusion criteria:

  • History of cerebral surgery
  • Neurological disorder that can interfere with evaluation of surgical procedure or significant cognitive impairment (Mattis score < 30)
  • Psychiatric disorder responsible for comorbidity with the major depressive episode (schizophrenia and other delirium, diagnosed anxiety except generalized anxiety disorder, substance dependency)
  • Personality disorder of A and B clusters
  • Suicidal ideas at evaluation, intention for auto-destruction, repeated suicidal attempts in the last 3 years with emergency care or hospitalization
  • Severe somatic pathology or contraindication to surgery due to heart defibrillator/pacemaker or other implanted device.
  • A decrease superior to or equal to 20% in the 17-Hamilton Depression Rating Scale score between inclusion and pre-surgery evaluation
  • Drug dependency including alcohol in the last 12 months with history of abuse in the last 6 months, with the exception of nicotine
  • Persons protected by the law.

Studieplan

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

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Change from Baseline of the Score at the Hamilton Depression Rating Scale
Tidsram: baseline, at 1 year
baseline, at 1 year

Sekundära resultatmått

Resultatmått
Tidsram
neurological examination
Tidsram: monthly during the first 6 mo and every 3 months until the end of the 1st year
monthly during the first 6 mo and every 3 months until the end of the 1st year

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional outcome and health status measured by Short Form Health Survey (SF-36) scale
Tidsram: at baseline, at 3 months, 12 months, 24 months
SF-36 scale assesses both physical and mental health status.
at baseline, at 3 months, 12 months, 24 months

Samarbetspartners och utredare

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

Sponsor

University Hospital, Grenoble

Utredare

  • Huvudutredare: Stephan CHABARDES, MD, PhD, University Hospital, Grenoble

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 december 2007

Primärt slutförande (Faktisk)

1 december 2017

Avslutad studie (Faktisk)

1 december 2017

Studieregistreringsdatum

Först inskickad

21 mars 2013

Först inskickad som uppfyllde QC-kriterierna

15 april 2013

Första postat (Uppskatta)

18 april 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 oktober 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 oktober 2018

Senast verifierad

1 oktober 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CG25

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 .

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