Best practices for clinical trials of deep brain stimulation for neuropsychiatric indications DOI Creative Commons
Alexandra Tremblay-McGaw, Elissa J. Hamlat,

Nílson Becker

et al.

Frontiers in Human Neuroscience, Journal Year: 2025, Volume and Issue: 19

Published: April 16, 2025

Deep brain stimulation (DBS) is well suited to target disorders with network dysregulation, as the case in many neuropsychiatric diseases. While DBS a well-established therapy for Parkinson's disease, essential tremor, dystonia, and medically refractory epilepsy, it actively being studied clinical trials including treatment-refractory major depressive disorder (MDD). Due nature of symptomology participant characteristics, special care must be taken design implementation testing disorders. In particular, these studies typically include multi-year relationships between participants study staff frequent interactions, high burden activities on participants, disclosure by sensitive information related symptoms disease state. Through our experience six across more than 5 years Presidio trial assessing personalized closed-loop MDD, we have gathered evidence inform best practices conducting interaction-intensive vulnerable population. Here, present Key Practices along discussion, informed multiple fundamental principles: The Belmont Report; emotional physical safety staff; integrity validity scientific outcomes.

Language: Английский

The “Wheels That Keep Me Goin’”: Invisible Forms of Support for Brain Pioneers DOI
Andrew Ivan Brown, Katherine E. MacDuffie, Sara Goering

et al.

Neuroethics, Journal Year: 2025, Volume and Issue: 18(1)

Published: March 26, 2025

Language: Английский

Citations

0
Best practices for clinical trials of deep brain stimulation for neuropsychiatric indications DOI Creative Commons
Alexandra Tremblay-McGaw, Elissa J. Hamlat,

Nílson Becker

et al.

Frontiers in Human Neuroscience, Journal Year: 2025, Volume and Issue: 19

Published: April 16, 2025

Deep brain stimulation (DBS) is well suited to target disorders with network dysregulation, as the case in many neuropsychiatric diseases. While DBS a well-established therapy for Parkinson's disease, essential tremor, dystonia, and medically refractory epilepsy, it actively being studied clinical trials including treatment-refractory major depressive disorder (MDD). Due nature of symptomology participant characteristics, special care must be taken design implementation testing disorders. In particular, these studies typically include multi-year relationships between participants study staff frequent interactions, high burden activities on participants, disclosure by sensitive information related symptoms disease state. Through our experience six across more than 5 years Presidio trial assessing personalized closed-loop MDD, we have gathered evidence inform best practices conducting interaction-intensive vulnerable population. Here, present Key Practices along discussion, informed multiple fundamental principles: The Belmont Report; emotional physical safety staff; integrity validity scientific outcomes.

Language: Английский

Citations

0