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A Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Tourette Syndrome

18. marts 2015 opdateret af: University College, London

A Randomised, Controlled, Crossover Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Severe Tourette Syndrome

The purpose of this study is to investigate whether deep brain stimulation (DBS) of the globus pallidus internum (GPi) can alleviate tics in Gilles de la Tourette syndrome (GTS) and whether this treatment has any influence on social, psychological and behavioral disability and quality of life.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is aimed at adults who have severe Tourette syndrome and who have found that conventional treatments, such as drugs, do not control their symptoms sufficiently or cannot be tolerated.

The first two clinic visits will involve assessments. Participants will fill in a number of questionnaires and be examined by a psychiatrist and a neurologist. At the second visit, the patient will provide consent for participation and will undergo formal tests to find out if the participant is suitable and willing to undergo the research study and to record the type and severity of their Tourette syndrome symptoms.

The third visit will be an admission to hospital to have the deep brain stimulation (DBS) devices implanted. The admission to hospital should be around five days in duration.

At the first post operative follow-up visit, the patient will be placed into a "stimulator on" group or a "stimulator off" group. To try and make sure that these groups are the same to start with, each patient is put into a group by chance (randomly). This visit will take place around six weeks after surgery. In this trial, the participant will have an equal chance of being in the "on" or the "off" group first. This trial is also a "blinded" trial, neither the patient nor the researchers performing the assessments will know which group the patient is in.

At the next visit, 3 months later, the patient will have a further assessment. If their stimulators have been "on" for the first 3 months, they will be switched off. If they have been "off" they will be switched on.

At the next visit, 3 months later, the patient will be assessed again and then given the opportunity to carry on the trial with the stimulators switched on for long term follow up.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. The participant must be adult with stable Tourette syndrome.
  2. The participant must have a chronic and severe tic disorder with severe functional impairment, with a Yale Tourette Severity Scale score of at least 35/55 for at least 12 months prior to surgery.
  3. The participant must have failed conventional medical treatment at therapeutic doses of three classes of medication.
  4. The participant must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful.
  5. The participant must have been on stable and optimised treatment of co-morbid conditions for at least 6 months.
  6. The participant must be actively involved with and compliant with any psychosocial interventions.
  7. The patient must be compliant with treatment plans.

Exclusion Criteria:

  1. The tic disorder is attributable to any other condition.
  2. Any other medical or psychiatric disorders that substantially increase the risk of a failed procedure or that would significantly impede recovery.
  3. Psychosocial factors which might impede operative and post-operative care and research participation.
  4. Coagulation problems
  5. Other disease compromising life expectancy
  6. Patient likely to benefit from psychological intervention
  7. Patient unwilling to co-operate with post operative assessment and care
  8. Pregnancy.
  9. Participant under 20 years old.

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: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: DBS Off first
Procedure: Bilateral GPi Deep Brain Stimulation
Bilateral GPi Deep Brain Stimulation
Eksperimentel: DBS On First
Procedure: Bilateral GPi Deep Brain Stimulation
Bilateral GPi Deep Brain Stimulation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Yale Global Tic Severity Scale
Tidsramme: Three months after stimulation switched ON v three months after stimulation switched OFF
The Change in Scores on the Yale Global Tic Severity Scale will be compared between defined periods with stimulation switched ON v stimulation switched OFF.
Three months after stimulation switched ON v three months after stimulation switched OFF

Sekundære resultatmål

Resultatmål
Tidsramme
Change in Modified Rush Video Rating scale
Tidsramme: Three months after stimulation switched ON v three months after stimulation switched OFF
Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Yale Brown Obsessive Compulsive Scale
Tidsramme: Three months after stimulation switched ON v three months after stimulation switched OFF
Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Neuropsychiatric Inventory
Tidsramme: Three months after stimulation switched ON v three months after stimulation switched OFF
Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Tourette Quality of life scale
Tidsramme: Three months after stimulation switched ON v three months after stimulation switched OFF
Three months after stimulation switched ON v three months after stimulation switched OFF
Change in MOVES scale
Tidsramme: Three months after stimulation switched ON v three months after stimulation switched OFF
Three months after stimulation switched ON v three months after stimulation switched OFF
Change in Beck Depression Inventory
Tidsramme: Three months after stimulation switched ON v three months after stimulation switched OFF
Three months after stimulation switched ON v three months after stimulation switched OFF

Samarbejdspartnere og efterforskere

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

Sponsor

University College, London

Efterforskere

  • Ledende efterforsker: Thomas Foltynie, MBBS PhD, UCL Institute of Neurology

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. juli 2011

Primær færdiggørelse (Faktiske)

1. november 2014

Studieafslutning (Faktiske)

1. november 2014

Datoer for studieregistrering

Først indsendt

16. juli 2012

Først indsendt, der opfyldte QC-kriterier

20. juli 2012

Først opslået (Skøn)

23. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UCL 11/0226

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 .

Kliniske forsøg med Tourettes syndrom

Kliniske forsøg med Bilateral GPi Deep Brain Stimulation

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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