Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa
調査の概要
詳細な説明
Anorexia nervosa is a chronic, and debilitating psychiatric disorder associated with the highest mortality rate of any psychiatric condition. Despite advances in neuroimaging, genetics, pharmacology and psychosocial interventions in the last half century, little progress have been made in altering the natural history of the condition or its outcomes. It has further become increasingly accepted that the thoughts and behaviors at the root of AN derive from dysfunctional neuroanatomic circuits, whose activity and deviations can be detected with sophisticated neuroimaging techniques. Much progress has also been made in mapping the psychology of the illness to underlying neuroanatomic and neurophysiologic processes that drive and maintain these behaviors, even in the face of severe starvation and impending death. Dysfunctional reward processing, compulsive hyperactivity, chronic anxiety and depression, all suggest that AN shares much in common with other conditions, such as OCD, for which surgical therapy has been tried, and met with success.
Deep Brain Stimulation is a neurosurgical tool that has been widely used for over twenty years. Most of the experience with DBS comes from the movement disorder literature where significant success has been had with the management of disabling Parkinson's disease (PD) and dystonia. The most experience so far has been in Parkinson's disease where well over 50,000 patients globally have received the operation. DBS is believed to work by using small amounts of electricity to disrupt the activity of brain structures that produce troublesome symptoms. DBS has also been used in psychiatric patients, both as part of treatment and research, in cases of Obsessive-Compulsive Disorder (OCD), and research, in cases of Depression. Current research suggests that there are similarities between Anorexia Nervosa and conditions such as OCD and depression. Given that DBS has shown promise in the treatment of those conditions, this trial was designed to see if it could be an effective therapy for Anorexia Nervosa as well.
This study would be the first exploration of a surgical therapy for refractory AN. The rationale stems from clear and robust evidence pointing at a dysfunctional cortical-subcortical loop driving abnormal behavior, with several important nodes in the loop being particularly important, and recurring, players. The subgenual cingulate plays a role in affective decision making, reward processing, as well as subsequent anxiety and dysphoric mood.
There are currently no brain based, targeted therapies for AN. The scientific significance of this study will be:
i) The first clinical trial exploring deep brain stimulation in an eating disorder population
ii) The first demonstration of the influence of deep brain stimulation on dysfunctional reward processing with co-morbid anxiety/dysphoria
iii) The first 'brain-based' treatment for any eating disorder
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
-
Toronto、Ontario、カナダ、M5T2S8
- Toronto Western Hospital
-
-
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:
- Female or Male patients between age 20-60
- Diagnosis of Anorexia Nervosa, restricting or binge-purging subtype as defined by the Diagnostic and Statistical Manual (DSM-IVR)
Chronicity and/or Treatment Resistance as demonstrated by some or all of:
- A pattern of three year's duration of relentless unresponsiveness to repeated voluntary hospitalizations, characterized by failure to complete treatment of immediate weight relapse following treatment;
- pattern of increasing medical instability accompanied by refusal to participate in/lack of responsiveness to intensive expert treatment and increasing medical acuity, lasting at least two years and involving at least two episodes of involuntary feeding;
- A pattern of chronic stable AN lasting at least 10 years
- Able to comply with all testing, follow-ups and study appointments and protocols
Exclusion Criteria:
- Any past or current evidence of psychosis
- Active neurologic disease such as epilepsy
- Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
- Any contraindication to Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scanning
- Likely to relocate or move during the study's one year duration
- BMI less than 13
- Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions as a result of AN or not, that will result in significant risk from a surgical procedure.
- Pregnancy
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:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Deep Brain Stimulation
|
Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone.
|
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 |
---|---|---|
Eating Disorder Related Preoccupations and Rituals
時間枠:Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
|
Eating Disorder Related Preoccupations and Rituals scores
|
Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Depression
時間枠:Change from baseline in depression scores at 3 months, 6 months and 12 months
|
Hamilton Depression Rating Scale (HAMD), Beck Depression Inventory (BDI)
|
Change from baseline in depression scores at 3 months, 6 months and 12 months
|
Anxiety
時間枠:Change from baseline in anxiety scores at 3 months, 6 months and 12 months
|
Beck Anxiety Inventory (BAI)
|
Change from baseline in anxiety scores at 3 months, 6 months and 12 months
|
Quality of Life questionnaire score through change from baseline compared to post-implant visit
時間枠:Change from baseline in Quality of Life scores at 3 months, 6 months and 12 months
|
Health Survey Short Form (SF36), Quality of Life Scale
|
Change from baseline in Quality of Life scores at 3 months, 6 months and 12 months
|
協力者と研究者
捜査官
- 主任研究者:Andres M Lozano, MD, PhD、University Health Network, Toronto
- 主任研究者:Blake Woodside, MD、Toronto General Hospital
出版物と役立つリンク
一般刊行物
- Lipsman N, Lam E, Volpini M, Sutandar K, Twose R, Giacobbe P, Sodums DJ, Smith GS, Woodside DB, Lozano AM. Deep brain stimulation of the subcallosal cingulate for treatment-refractory anorexia nervosa: 1 year follow-up of an open-label trial. Lancet Psychiatry. 2017 Apr;4(4):285-294. doi: 10.1016/S2215-0366(17)30076-7. Epub 2017 Feb 24.
- Lipsman N, Woodside DB, Giacobbe P, Hamani C, Carter JC, Norwood SJ, Sutandar K, Staab R, Elias G, Lyman CH, Smith GS, Lozano AM. Subcallosal cingulate deep brain stimulation for treatment-refractory anorexia nervosa: a phase 1 pilot trial. Lancet. 2013 Apr 20;381(9875):1361-1370. doi: 10.1016/S0140-6736(12)62188-6. Epub 2013 Mar 7.
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 (実際)
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。
Deep Brain Stimulationの臨床試験
-
St. Joseph's Healthcare HamiltonPeter Boris Centre for Addictions Research (PBCAR)募集
-
Rotman Research Institute at BaycrestCentre for Addiction and Mental Health; Brainsway募集
-
BeerYaakov Mental Health CenterWeizmann Institute of Scienceわからない