Evidence map›Paper›PMID 40309667›Full record

ArticleFrontiers in human neuroscience2025

Best practices for clinical trials of deep brain stimulation for neuropsychiatric indications.

Alexandra G Tremblay-McGaw, Elissa J Hamlat, Natalie C Becker, Daniela A Astudillo Maya, Andrew D Krystal, Kristin K Sellers

Abstract read
In one paragraph

Article in Frontiers in human neuroscience, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Alexandra G Tremblay-McGawDepartment of Psychiatry and Behavioral Sciences, University of California, San Francisco, San Francisco, CA, United States.
Elissa J HamlatDepartment of Psychiatry and Behavioral Sciences, University of California, San Francisco, San Francisco, CA, United States.
Natalie C BeckerDepartment of Psychiatry and Behavioral Sciences, University of California, San Francisco, San Francisco, CA, United States.
Daniela A Astudillo MayaDepartment of Psychiatry and Behavioral Sciences, University of California, San Francisco, San Francisco, CA, United States.
Andrew D KrystalDepartment of Psychiatry and Behavioral Sciences, University of California, San Francisco, San Francisco, CA, United States.
Kristin K SellersWeill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

Indexed as

best practicesclinical trialsdeep brain stimulationmajor depressive disorderneuroethicsneuropsychiatric diseases

Identifiers

PMID40309667
PMCPMC12041084

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.