A human rights approach to low data reporting in clinical trials of psychiatric deep brain stimulation

Bioethics ◽  
2019 ◽  
Vol 33 (9) ◽  
pp. 1050-1058
Author(s):  
Laura Y. Cabrera
Keyword(s):  
Clinical Trials ◽  
Human Rights ◽  
Deep Brain Stimulation ◽  
Brain Stimulation ◽  
Data Reporting ◽  
Deep Brain

Psychiatric neurosurgery

2018 ◽  
pp. 135-184
Author(s):  
Walter Glannon
Keyword(s):  
Clinical Trials ◽  
Deep Brain Stimulation ◽  
Brain Stimulation ◽  
Neural Circuits ◽  
Therapeutic Potential ◽  
Genetic Material ◽  
Research Subjects ◽  
Ethical Justification ◽  
The Brain ◽  
Deep Brain

This chapter discusses functional neurosurgery designed to modulate dysfunctional neural circuits mediating sensorimotor, cognitive, emotional, and volitional capacities. The chapter assesses the comparative benefits and risks of neural ablation and deep brain stimulation as the two most invasive forms of neuromodulation. It discusses the question of whether individuals with a severe or moderately severe psychiatric disorder have enough cognitive and emotional capacity to weigh reasons for and against ablation or deep brain stimulation and give informed consent to undergo it. The chapter also discusses the obligations of investigators conducting these trials to research subjects. In addition, it examines the medical and ethical justification for a sham control arm in psychiatric neurosurgery clinical trials. It considers the therapeutic potential of optogenetics as a novel form of neuromodulation. The fact that this technique manipulates both genetic material and neural circuits and has been tested only in animal models makes it unclear what its benefit–risk ratio would be. The chapter concludes with a brief discussion of the potential of neuromodulation to stimulate endogenous repair and growth mechanisms in the brain.

scholarly journals Publication of Study Exit Procedures in Clinical Trials of Deep Brain Stimulation: A Focused Literature Review

2020 ◽  
Vol 14 ◽  
Author(s):  
Lauren R. Sankary ◽  
Akila M. Nallapan ◽  
Olivia Hogue ◽  
Andre G. Machado ◽  
Paul J. Ford
Keyword(s):  
Clinical Trials ◽  
Deep Brain Stimulation ◽  
Literature Review ◽  
Brain Stimulation ◽  
Deep Brain

scholarly journals “Nothing to Lose, Absolutely Everything to Gain”: Patient and Caregiver Expectations and Subjective Outcomes of Deep Brain Stimulation for Treatment-Resistant Depression

2021 ◽  
Vol 15 ◽  
Author(s):  
Cassandra J. Thomson ◽  
Rebecca A. Segrave ◽  
Paul B. Fitzgerald ◽  
Karyn E. Richardson ◽  
Eric Racine ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Deep Brain Stimulation ◽  
Informed Consent ◽  
Brain Stimulation ◽  
Family Needs ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Structured Interviews ◽  
Resistant Depression ◽  
Deep Brain

Background: How “success” is defined in clinical trials of deep brain stimulation (DBS) for refractory psychiatric conditions has come into question. Standard quantitative psychopathology measures are unable to capture all changes experienced by patients and may not reflect subjective beliefs about the benefit derived. The decision to undergo DBS for treatment-resistant depression (TRD) is often made in the context of high desperation and hopelessness that can challenge the informed consent process. Partners and family can observe important changes in DBS patients and play a key role in the recovery process. Their perspectives, however, have not been investigated in research to-date. The aim of this study was to qualitatively examine patient and caregivers’ understanding of DBS for TRD, their expectations of life with DBS, and how these compare with actual experiences and outcomes.Methods: A prospective qualitative design was adopted. Semi-structured interviews were conducted with participants (six patients, five caregivers) before DBS-implantation and 9-months after stimulation initiation. All patients were enrolled in a clinical trial of DBS of the bed nucleus of the stria terminalis. Interviews were thematically analyzed with data saturation achieved at both timepoints.Results: Two primary themes identified were: (1) anticipated vs. actual outcomes, and (2) trial decision-making and knowledge. The decision to undergo DBS was driven by the intolerability of life with severe depression coupled with the exhaustion of all available treatment options. Participants had greater awareness of surgical risks compared with stimulation-related risks. With DBS, patients described cognitive, emotional, behavioral and physical experiences associated with the stimulation, some of which were unexpected. Participants felt life with DBS was like “a roller coaster ride”—with positive, yet unsustained, mood states experienced. Many were surprised by the lengthy process of establishing optimum stimulation settings and felt the intervention was still a “work in progress.”Conclusion: These findings support existing recommendations for iterative informed consent procedures in clinical trials involving long-term implantation of neurotechnology. These rich and descriptive findings hold value for researchers, clinicians, and individuals and families considering DBS. Narrative accounts capture patient and family needs and should routinely be collected to guide patient-centered approaches to DBS interventions.

Deep Brain Stimulation for Alzheimer’s Disease

2017 ◽  
Vol 14 (4) ◽  
pp. 356-361 ◽  
Author(s):  
David S. Xu ◽  
Francisco A. Ponce
Keyword(s):  
Clinical Trials ◽  
Deep Brain Stimulation ◽  
Brain Stimulation ◽  
High Frequency ◽  
Memory Disorders ◽  
Motor Circuits ◽  
Chronic Electrical Stimulation ◽  
Mood And Cognition ◽  
The Brain ◽  
Deep Brain

High-frequency deep brain stimulation (DBS) was introduced in the late 1980s for the treatment of movement disorders. This reversible, adjustable, and non-ablative therapy has been used to treat more than 100,000 people worldwide. The surgical procedure used to implant the DBS system, as well as the effects of chronic electrical stimulation, have been shown to be safe and effective through many clinical trials. Given the ability to therapeutically modulate the motor circuits of the brain in this manner, clinicians have considered using DBS for other neurodegenerative and neuropsychiatric disorders involving non-motor circuits, including appetite, mood, and cognition. This article highlights several recent studies exploring the feasibility of using DBS to modulate memory, specifically in the context of memory disorders such as Alzheimer disease.

scholarly journals Deep brain stimulation for refractory obsessive-compulsive disorder (OCD): emerging or established therapy?

2020 ◽  
Author(s):  
Hemmings Wu ◽  
Marwan Hariz ◽  
Veerle Visser-Vandewalle ◽  
Ludvic Zrinzo ◽  
Volker A. Coenen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Deep Brain Stimulation ◽  
Obsessive Compulsive Disorder ◽  
Brain Stimulation ◽  
Brain Area ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
Randomized Controlled ◽  
Treatment Refractory ◽  
Deep Brain

Abstract A consensus has yet to emerge whether deep brain stimulation (DBS) for treatment-refractory obsessive-compulsive disorder (OCD) can be considered an established therapy. In 2014, the World Society for Stereotactic and Functional Neurosurgery (WSSFN) published consensus guidelines stating that a therapy becomes established when “at least two blinded randomized controlled clinical trials from two different groups of researchers are published, both reporting an acceptable risk-benefit ratio, at least comparable with other existing therapies. The clinical trials should be on the same brain area for the same psychiatric indication.” The authors have now compiled the available evidence to make a clear statement on whether DBS for OCD is established therapy. Two blinded randomized controlled trials have been published, one with level I evidence (Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score improved 37% during stimulation on), the other with level II evidence (25% improvement). A clinical cohort study (N = 70) showed 40% Y-BOCS score improvement during DBS, and a prospective international multi-center study 42% improvement (N = 30). The WSSFN states that electrical stimulation for otherwise treatment refractory OCD using a multipolar electrode implanted in the ventral anterior capsule region (including bed nucleus of stria terminalis and nucleus accumbens) remains investigational. It represents an emerging, but not yet established therapy. A multidisciplinary team involving psychiatrists and neurosurgeons is a prerequisite for such therapy, and the future of surgical treatment of psychiatric patients remains in the realm of the psychiatrist.

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