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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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London、イギリス
- UCL Institute of Neurology
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:DBS Off first
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Bilateral GPi Deep Brain Stimulation
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実験的:DBS On First
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Bilateral GPi Deep Brain Stimulation
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Yale Global Tic Severity Scale
時間枠: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
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in Modified Rush Video Rating scale
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Thomas Foltynie, MBBS PhD、UCL Institute of Neurology
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。