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

18 maart 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

15

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: DBS Off first
Bilateral GPi Deep Brain Stimulation
Experimenteel: DBS On First
Bilateral GPi Deep Brain Stimulation

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Yale Global Tic Severity Scale
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change in Modified Rush Video Rating scale
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Thomas Foltynie, MBBS PhD, UCL Institute of Neurology

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2011

Primaire voltooiing (Werkelijk)

1 november 2014

Studie voltooiing (Werkelijk)

1 november 2014

Studieregistratiedata

Eerst ingediend

16 juli 2012

Eerst ingediend dat voldeed aan de QC-criteria

20 juli 2012

Eerst geplaatst (Schatting)

23 juli 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

19 maart 2015

Laatste update ingediend die voldeed aan QC-criteria

18 maart 2015

Laatst geverifieerd

1 maart 2015

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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