International Regulatory Standards for the Qualitative Measurement of Deep Brain Stimulation in Clinical Research

Abstract

Deep brain stimulation (DBS) has progressed to become a promising treatment modality for neurologic and psychiatric disorders like epilepsy and major depressive disorder due to its growing personalization. Despite evidence pointing to the benefits of DBS if tested on these personalized qualitative metrics, rather than randomized-control trial quantitative standards, the evaluation of these novel devices appears to be based on the latter. This study surveyed the presence of this trend in the national regulatory guidelines of the prominent DBS researching countries. It was found that two governing bodies, in the European Union and Australia, acknowledged the option for qualitative measures. These findings support further development of national regulatory guidelines, so the neuroscientific community developing these neurotechnologies can better understand the impact their treatments have on patients.

Happy Birthday “One Flew Over the Cuckoo's Nest”: A Momentous Tale in the Quest for an Effective and Ethical Approach to Psychosurgery

“…The absence of distinct macroscopic brain pathology specifically associated with these mental disorders within the cortico-striato-thalamo-cortical pathways renders precise identification of brain surgical targets challenging, resulting in variable clinical improvement. 17 Target regions are chosen based on the balance between the desired outcome and the risk of side effects whilst surgery is offered only to patients with severe syndromes with multiple less invasive treatment failures. Current ablative techniques include anterior capsulotomy for OCD and MDD, cingulotomy for OCD, MDD and addiction (Add), limbic leucotomy (OCD), subcaudate tractotomy (OCD and MDD) and lesions in the nucleus accumbens (Add).…”

“…The implant can be "switched on" and "adjusted" whereas, in case of a lack of efficacy, it can be "switched off" without incurring irreversible brain damage. 17 These features provide important opportunities to establish the efficacy of these approaches. There is the potential to do blinded studies where the stimulus can be turned on and off or modified with either the patient and/or rater blind to what has been changed.…”

“…In contrast to mental health applications, the use of DBS to treat neurological disorders including epilepsy, pain syndromes, Parkinson's disease and dystonia is more established, even in relatively early stages of disease progression. 17,18 In DBS, an anode and cathode are implanted within the brain, under MRI and stereotactic guidance, in deep brain regions to deliver a small electric current. The electrodes are connected to a stimulator located under the skin of the upper chest.…”

“…In contrast to mental health applications, the use of DBS to treat neurological disorders including epilepsy, pain syndromes, Parkinson's disease and dystonia is more established, even in relatively early stages of disease progression. 17,18…”