- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01647269
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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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London, Zjednoczone Królestwo
- UCL Institute of Neurology
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: DBS Off first
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Bilateral GPi Deep Brain Stimulation
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Eksperymentalny: DBS On First
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Bilateral GPi Deep Brain Stimulation
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change in Yale Global Tic Severity Scale
Ramy czasowe: 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.
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Three months after stimulation switched ON v three months after stimulation switched OFF
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
---|---|
Change in Modified Rush Video Rating scale
Ramy czasowe: Three months after stimulation switched ON v three months after stimulation switched OFF
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Three months after stimulation switched ON v three months after stimulation switched OFF
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Change in Yale Brown Obsessive Compulsive Scale
Ramy czasowe: Three months after stimulation switched ON v three months after stimulation switched OFF
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Three months after stimulation switched ON v three months after stimulation switched OFF
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Change in Neuropsychiatric Inventory
Ramy czasowe: Three months after stimulation switched ON v three months after stimulation switched OFF
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Three months after stimulation switched ON v three months after stimulation switched OFF
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Change in Tourette Quality of life scale
Ramy czasowe: Three months after stimulation switched ON v three months after stimulation switched OFF
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Three months after stimulation switched ON v three months after stimulation switched OFF
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Change in MOVES scale
Ramy czasowe: Three months after stimulation switched ON v three months after stimulation switched OFF
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Three months after stimulation switched ON v three months after stimulation switched OFF
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Change in Beck Depression Inventory
Ramy czasowe: Three months after stimulation switched ON v three months after stimulation switched OFF
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Three months after stimulation switched ON v three months after stimulation switched OFF
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Thomas Foltynie, MBBS PhD, UCL Institute of Neurology
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Procesy patologiczne
- Choroby mózgu
- Choroby ośrodkowego układu nerwowego
- Choroby Układu Nerwowego
- Choroba
- Choroby genetyczne, wrodzone
- Choroby jąder podstawy
- Zaburzenia ruchowe
- Choroby neurodegeneracyjne
- Choroby zwyrodnieniowe układu nerwowego
- Zaburzenia neurorozwojowe
- Zaburzenia tikowe
- Zespół
- Zespół Tourette'a
Inne numery identyfikacyjne badania
- UCL 11/0226
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Zespół Tourette'a
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Centre Hospitalier Universitaire DijonNovartis PharmaceuticalsRekrutacyjnyMegalencephaly-włośniczkowy zespół polimikrogyrii (MCAP)Francja