An Open-Label Clinical Trial of Hypothalamic Deep Brain Stimulation for Human Morbid Obesity: BLESS Study Protocol

Neurosurgery ◽  
2018 ◽  
Vol 83 (4) ◽  
pp. 800-809 ◽  
Author(s):  
Antonio A F De Salles ◽  
Daniel A N Barbosa ◽  
Fernando Fernandes ◽  
Julio Abucham ◽  
Debora M Nazato ◽  
...  
Keyword(s):  
Morbid Obesity ◽  
Weight Loss ◽  
Body Composition ◽  
Electrical Stimulation ◽  
Deep Brain Stimulation ◽  
Side Effects ◽  
Food Intake ◽  
Brain Stimulation ◽  
Open Label ◽  
Deep Brain

Abstract BACKGROUND Human morbid obesity is increasing worldwide in an alarming way. The hypothalamus is known to mediate its mechanisms. Deep brain stimulation (DBS) of the ventromedial hypothalamus (VMH) may be an alternative to treat patients refractory to standard medical and surgical therapies. OBJECTIVE To assess the safety, identify possible side effects, and to optimize stimulation parameters of continuous VMH-DBS. Additionally, this study aims to determine if continuous VMH-DBS will lead to weight loss by causing changes in body composition, basal metabolism, or food intake control. METHODS The BLESS study is a feasibility study, single-center open-label trial. Six patients (body mass index > 40) will undergo low-frequency VMH-DBS. Data concerning timing, duration, frequency, severity, causal relationships, and associated electrical stimulation patterns regarding side effects or weight changes will be recorded. EXPECTED OUTCOMES We expect to demonstrate the safety, identify possible side effects, and to optimize electrophysiological parameters related to VMH-DBS. No clinical or behavioral adverse changes are expected. Weight loss ≥ 3% of the basal weight after 3 mo of electrical stimulation will be considered adequate. Changes in body composition and increase in basal metabolism are expected. The amount of food intake is likely to remain unchanged. DISCUSSION The design of this study protocol is to define the safety of the procedure, the surgical parameters important for target localization, and additionally the safety of long-term stimulation of the VMH in morbidly obese patients. Novel neurosurgical approaches to treat metabolic and autonomic diseases can be developed based on the data made available by this investigation.

Deep brain stimulation for treatment of obesity in rats

2007 ◽  
Vol 107 (4) ◽  
pp. 809-813 ◽  
Author(s):  
Sepehr Sani ◽  
Kirk Jobe ◽  
Adam Smith ◽  
Jeffrey H. Kordower ◽  
Roy A. E. Bakay
Keyword(s):  
Weight Loss ◽  
Weight Gain ◽  
Deep Brain Stimulation ◽  
Food Intake ◽  
Brain Stimulation ◽  
Hypothalamic Nucleus ◽  
Control Group ◽  
Sprague Dawley ◽  
Treatment Of Obesity ◽  
Deep Brain

Object Given the success of deep brain stimulation (DBS) in a variety of applications (for example, Parkinson disease and essential tremor), other indications for which there is currently little effective therapy are being evaluated for clinical use of DBS. Obesity may be one such indication. Studies of the control of feeding and appetite by neurosurgical lesioning have been completed previously. This study was conducted to test the authors' hypothesis that continuous bilateral stimulatory inhibition of the rat lateral hypothalamic nucleus (LH) would lead to significant and sustained decrease in food intake and subsequent weight loss. Methods Sixteen Sprague–Dawley rats were maintained on a high-fat diet. Daily food intake and weight gain were measured for 7 days, at which time the animals underwent stereotactic placement of 0.25-mm-diameter bipolar stimulating electrodes bilaterally in the LH. On postoperative Day 7, eight animals began to receive continuous stimulation of the LH. The remaining eight animals were left unstimulated as the control group. Individual animal weight, food intake, and water intake were monitored daily and continuously throughout the experiment until postoperative Day 24. Results There was a decreased rate of weight gain after surgery in all animals, but the unstimulated group recovered and resumed a linear weight gain curve. The stimulated group, however, failed to show weight gain and remained below the mean baseline for body mass. There was a significant weight loss between the stimulated and unstimulated groups. On postoperative Day 24, compared with the day of surgery (Day 0), the unstimulated group had a mean weight gain of 13.8%, whereas the stimulated group had a 2.3% weight loss on average (p = 0.001), yielding a 16.1% weight difference between the two groups. Conclusions Bilateral electrical stimulatory inhibition of the LH is effective in causing significant and sustained weight loss in rats.

scholarly journals Deep Brain Stimulation of the Posterior Insula in Chronic Pain: A Theoretical Framework

2021 ◽  
Vol 11 (5) ◽  
pp. 639
Author(s):  
David Bergeron ◽  
Sami Obaid ◽  
Marie-Pierre Fournier-Gosselin ◽  
Alain Bouthillier ◽  
Dang Khoa Nguyen
Keyword(s):  
Chronic Pain ◽  
Electrical Stimulation ◽  
Deep Brain Stimulation ◽  
Brain Stimulation ◽  
High Frequency ◽  
Brain Lesion ◽  
Low Frequency ◽  
Posterior Insula ◽  
Deep Brain ◽  
Stimulation Of

Introduction: To date, clinical trials of deep brain stimulation (DBS) for refractory chronic pain have yielded unsatisfying results. Recent evidence suggests that the posterior insula may represent a promising DBS target for this indication. Methods: We present a narrative review highlighting the theoretical basis of posterior insula DBS in patients with chronic pain. Results: Neuroanatomical studies identified the posterior insula as an important cortical relay center for pain and interoception. Intracranial neuronal recordings showed that the earliest response to painful laser stimulation occurs in the posterior insula. The posterior insula is one of the only regions in the brain whose low-frequency electrical stimulation can elicit painful sensations. Most chronic pain syndromes, such as fibromyalgia, had abnormal functional connectivity of the posterior insula on functional imaging. Finally, preliminary results indicated that high-frequency electrical stimulation of the posterior insula can acutely increase pain thresholds. Conclusion: In light of the converging evidence from neuroanatomical, brain lesion, neuroimaging, and intracranial recording and stimulation as well as non-invasive stimulation studies, it appears that the insula is a critical hub for central integration and processing of painful stimuli, whose high-frequency electrical stimulation has the potential to relieve patients from the sensory and affective burden of chronic pain.

P41 Psychiatric side effects of bilateral deep brain stimulation for movement disorders

Basal Ganglia ◽  
2011 ◽  
Vol 1 (2) ◽  
pp. 120-121
Author(s):  
M.O. Pinsker ◽  
F. Amtage ◽  
M. Berger ◽  
G. Nikkhah ◽  
L. Tebartz van Elst
Keyword(s):  
Deep Brain Stimulation ◽  
Side Effects ◽  
Brain Stimulation ◽  
Movement Disorders ◽  
Psychiatric Side Effects ◽  
Deep Brain

scholarly journals Conceptualization and validation of an open-source closed-loop deep brain stimulation system in rat

2015 ◽  
Vol 5 (1) ◽  
Author(s):  
Hemmings Wu ◽  
Hartwin Ghekiere ◽  
Dorien Beeckmans ◽  
Tim Tambuyzer ◽  
Kris van Kuyck ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Deep Brain Stimulation ◽  
Open Source ◽  
Brain Stimulation ◽  
Closed Loop ◽  
Symptom Control ◽  
Theta Oscillations ◽  
Open Source Hardware ◽  
Hippocampal Theta ◽  
Deep Brain

Abstract Conventional deep brain stimulation (DBS) applies constant electrical stimulation to specific brain regions to treat neurological disorders. Closed-loop DBS with real-time feedback is gaining attention in recent years, after proved more effective than conventional DBS in terms of pathological symptom control clinically. Here we demonstrate the conceptualization and validation of a closed-loop DBS system using open-source hardware. We used hippocampal theta oscillations as system input and electrical stimulation in the mesencephalic reticular formation (mRt) as controller output. It is well documented that hippocampal theta oscillations are highly related to locomotion, while electrical stimulation in the mRt induces freezing. We used an Arduino open-source microcontroller between input and output sources. This allowed us to use hippocampal local field potentials (LFPs) to steer electrical stimulation in the mRt. Our results showed that closed-loop DBS significantly suppressed locomotion compared to no stimulation and required on average only 56% of the stimulation used in open-loop DBS to reach similar effects. The main advantages of open-source hardware include wide selection and availability, high customizability and affordability. Our open-source closed-loop DBS system is effective and warrants further research using open-source hardware for closed-loop neuromodulation.

scholarly journals Evaluation of Automatic Segmentation of Thalamic Nuclei through Clinical Effects Using Directional Deep Brain Stimulation Leads: A Technical Note

2020 ◽  
Vol 10 (9) ◽  
pp. 642
Author(s):  
Marie T. Krüger ◽  
Rebecca Kurtev-Rittstieg ◽  
Georg Kägi ◽  
Yashar Naseri ◽  
Stefan Hägele-Link ◽  
...  
Keyword(s):  
Deep Brain Stimulation ◽  
Side Effects ◽  
Brain Stimulation ◽  
Technical Note ◽  
Patient Specific ◽  
Brain Anatomy ◽  
Clinical Effects ◽  
Thalamic Nuclei ◽  
Lead Placement ◽  
Deep Brain

Automatic anatomical segmentation of patients’ anatomical structures and modeling of the volume of tissue activated (VTA) can potentially facilitate trajectory planning and post-operative programming in deep brain stimulation (DBS). We demonstrate an approach to evaluate the accuracy of such software for the ventral intermediate nucleus (VIM) using directional leads. In an essential tremor patient with asymmetrical brain anatomy, lead placement was adjusted according to the suggested segmentation made by the software (Brainlab). Postoperatively, we used directionality to assess lead placement using side effect testing (internal capsule and sensory thalamus). Clinical effects were then compared to the patient-specific visualization and VTA simulation in the GUIDE™ XT software (Boston Scientific). The patient’s asymmetrical anatomy was correctly recognized by the software and matched the clinical results. VTA models matched best for dysarthria (6 out of 6 cases) and sensory hand side effects (5/6), but least for facial side effects (1/6). Best concordance was observed for the modeled current anterior and back spread of the VTA, worst for the current side spread. Automatic anatomical segmentation and VTA models can be valuable tools for DBS planning and programming. Directional DBS leads allow detailed postoperative assessment of the concordance of such image-based simulation and visualization with clinical effects.

scholarly journals Adaptive deep brain stimulation as advanced Parkinson’s disease treatment (ADAPT study): protocol for a pseudo-randomised clinical study

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e029652 ◽  
Author(s):  
Dan Piña-Fuentes ◽  
Martijn Beudel ◽  
Simon Little ◽  
Peter Brown ◽  
D L Marinus Oterdoom ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Deep Brain Stimulation ◽  
Clinical Study ◽  
Side Effects ◽  
Brain Stimulation ◽  
Rating Scale ◽  
Motor Symptoms ◽  
Internal Globus Pallidus ◽  
Deep Brain

IntroductionAdaptive deep brain stimulation (aDBS), based on the detection of increased beta oscillations in the subthalamic nucleus (STN), has been assessed in patients with Parkinson’s disease (PD) during the immediate postoperative setting. In these studies, aDBS was shown to be at least as effective as conventional DBS (cDBS), while stimulation time and side effects were reduced. However, the effect of aDBS on motor symptoms and stimulation-induced side effects during the chronically implanted phase (after the stun effect of DBS placement has disappeared) has not yet been determined.Methods and analysisThis protocol describes a single-centre clinical study in which aDBS will be tested in 12 patients with PD undergoing battery replacement, with electrodes implanted in the STN, and as a proof of concept in the internal globus pallidus. Patients included will be allocated in a pseudo-randomised fashion to a three-condition (no stimulation/cDBS/ aDBS), cross-over design. A battery of tests will be conducted and recorded during each condition, which aim to measure the severity of motor symptoms and side effects. These tests include a tablet-based tapping test, a subscale of the Movement Disorder Society-unified Parkinson’s disease rating scale (subMDS-UPDRS), the Speech Intelligibility Test (SIT) and a tablet-based version of the Stroop test. SubMDS-UPDRS and SIT recordings will be blindly assessed by independent raters. Data will be analysed using a linear mixed-effects model.Ethics and disseminationThis protocol was approved by the Ethical Committee of the University Medical Centre Groningen, where the study will be carried out. Data management and compliance to research policies and standards of our centre, including data privacy, storage and veracity, will be controlled by an independent monitor. All the scientific findings derived from this protocol are aimed to be made public through publication of articles in international journals.Trial registration numberNTR 5456; Pre-results.

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