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A Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Tourette Syndrome
A Randomised, Controlled, Crossover Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Severe Tourette Syndrome
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
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
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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London, Verenigd Koninkrijk
- UCL Institute of Neurology
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- The participant must be adult with stable Tourette syndrome.
- 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.
- The participant must have failed conventional medical treatment at therapeutic doses of three classes of medication.
- The participant must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful.
- The participant must have been on stable and optimised treatment of co-morbid conditions for at least 6 months.
- The participant must be actively involved with and compliant with any psychosocial interventions.
- The patient must be compliant with treatment plans.
Exclusion Criteria:
- The tic disorder is attributable to any other condition.
- Any other medical or psychiatric disorders that substantially increase the risk of a failed procedure or that would significantly impede recovery.
- Psychosocial factors which might impede operative and post-operative care and research participation.
- Coagulation problems
- Other disease compromising life expectancy
- Patient likely to benefit from psychological intervention
- Patient unwilling to co-operate with post operative assessment and care
- Pregnancy.
- Participant under 20 years old.
Studie plan
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
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Bilateral GPi Deep Brain Stimulation
|
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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
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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
Sponsor
Onderzoekers
- Hoofdonderzoeker: Thomas Foltynie, MBBS PhD, UCL Institute of Neurology
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Pathologische processen
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Ziekte
- Genetische ziekten, aangeboren
- Basale ganglia-ziekten
- Bewegingsstoornissen
- Neurodegeneratieve ziekten
- Heredodegeneratieve aandoeningen, zenuwstelsel
- Neurologische ontwikkelingsstoornissen
- Tic aandoeningen
- Syndroom
- Tourette syndroom
Andere studie-ID-nummers
- UCL 11/0226
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