Deep Brain Stimulation of the Bilateral Habenula for Treatment-Refractory Obsessive-Compulsive Disorder
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|ClinicalTrials.gov Identifier: NCT03463590|
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 29, 2018
Deep brain stimulation (DBS) offers an effective and safe treatment for patients with debilitating, otherwise treatment-refractory obsessive-compulsive disorder(OCD). Although several target areas for DBS have been used for OCD, such as the ventral capsule/ventral striatum and the subthalamic nucleus, not all patients show a clinical response, varying from 10% to 61.5%. Exploring new DBS targets may be a key approach to improve this situation. The habenula is an evolutionarily conserved structure playing an important role in depression, punishment avoiding, reward, addiction, pain and circadian rhythms. The habenula can be considered a promising target for OCD treatment based on the following hypotheses and clinical observations.
- The lateral habenula DBS has significant clinical antidepressant effects.
- The habenula plays an important role in the regulation of dopamine and serotonin systems.
- Selective serotonin reuptake inhibitors, the first line treatment for OCD, are commonly used to treat clinical depression.
- The habenula serves as a 'negative reward center' that mediates or moderates stress, negative emotions and thoughts, aversive learning, and goal-directed behavior, which are core clinical symptoms and signs of OCD.
- In our hospital, DBS of the habenula produced a significant improvement in OCD symptoms in one patient who failed to respond to other treatments, including capsulotomy either alone or in combination combined with cingulumotomy.
These theoretical and clinical considerations indicate that the habenula can be seen as a promising DBS target for OCD treatment. This study is focused on the effectiveness of bilateral DBS of the habenula for patients with treatment-refractory OCD. Furthermore, the study is aimed at exploring the influence of DBS of the habenula on brain activity and cognition.
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Device: Bilateral surgical implantation of DBS system to habenula||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects will receive bilateral surgical implantation of DBS system|
|Masking:||None (Open Label)|
|Official Title:||Deep Brain Stimulation of the Bilateral Habenula for Treatment-Refractory Obsessive-Compulsive Disorder|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||February 28, 2020|
All subjects will undergo bilateral surgical implantation of DBS system to habenula. The DBS system will be active at one week after surgery.
Device: Bilateral surgical implantation of DBS system to habenula
The DBS device utilized in the present study may include the Medtronic, PINS and SceneRay DBS device depending on patients' choice.
- Change in Y-BOCSII Score [ Time Frame: Baseline (preoperative),1 month, 3 months,6 months, 9 months ]The score of the scale ranges from 0 to 50
- Change in OCI-R Score [ Time Frame: Baseline (preoperative),1 month, 3 months,6 months, 9 months ]The score of the scale ranges from 0 to 72
- changes in the Hamilton Depression Scale(HAMD-17) [ Time Frame: Baseline（preoperative）,1 month, 3 months, 6 months,9 months ]The score of the scale ranges from 0 to 50
- changes in the Hamilton Anxiety Scale(HAMA-14) [ Time Frame: Baseline（preoperative）,1 month, 3 months, 6 months,9 months ]The score of the scale ranges from 0 to 56
- changes in FMRI signal [ Time Frame: Baseline（preoperative）,3 month, 6 months, 9 months ]The FMRI signal is to estimate Blood Oxygenation Level Dependent (BOLD) and connectivity of brain areas
- changes in World Health Organization Quality of Life-BREF(WHO-BREF) [ Time Frame: Baseline（preoperative）,1 month, 3 months,6 months,9 months ]
- changes the MOS item short from health survey (SF-36) [ Time Frame: Baseline（preoperative）,1 month, 3 months,6 months,9 months ]
- Neuropsychological measures(Scores of cogstate battery) [ Time Frame: Baseline（preoperative）,1 month, 3months,6months,9months ]Neuropsychological measures contains six tasks which are detection task, identification task, one card learning task, one back task, Groton maze learning task, set-shifting task
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463590
|Contact: Yingying Zhang, MScemail@example.com|
|Shanghai Ruijin Hospital Functional Neurosurgery||Recruiting|
|Shanghai, Shanghai, China, 200025|
|Contact: Chencheng Zhang, MD +086-18217122884 firstname.lastname@example.org|
|Contact: Yingying Zhang, MSc +086-17602137369 email@example.com|