Evidence map›Paper›PMID 36248692›Full record

SynthesisFrontiers in human neuroscience2022

Safety of deep brain stimulation in pregnancy: A comprehensive review.

Caroline King, T Maxwell Parker, Kay Roussos-Ross, Adolfo Ramirez-Zamora, John C Smulian, Michael S Okun, Joshua K Wong

Abstract readSystematic Review
In one paragraph

Synthesis in Frontiers in human neuroscience, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. 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

7 authors.

Caroline KingDepartment of Obstetrics & Gynecology, University of Florida College of Medicine, Gainesville, FL, United States.
T Maxwell ParkerDepartment of Neurology, Norman Fixel Institute for Neurological Diseases, University of Florida College of Medicine, Gainesville, FL, United States.
Kay Roussos-RossDepartment of Obstetrics & Gynecology, University of Florida College of Medicine, Gainesville, FL, United States.
Adolfo Ramirez-ZamoraDepartment of Neurology, Norman Fixel Institute for Neurological Diseases, University of Florida College of Medicine, Gainesville, FL, United States.
John C SmulianDepartment of Obstetrics & Gynecology, University of Florida College of Medicine, Gainesville, FL, United States.
Michael S OkunDepartment of Neurology, Norman Fixel Institute for Neurological Diseases, University of Florida College of Medicine, Gainesville, FL, United States.
Joshua K WongDepartment of Neurology, Norman Fixel Institute for Neurological Diseases, University of Florida College of Medicine, Gainesville, FL, United States.

Funding

Defining Targets for Tic Detection and Suppression in Tourette Syndrome Deep Brain StimulationUH3NS119844 · NINDS · UNIVERSITY OF FLORIDA · PI BUTSON, CHRISTOPHER R, GUNDUZ, AYSEGUL · 2021 to 2025
$5.0M
Web-based Automated Imaging Differentiation of ParkinsonismU01NS119562 · NINDS · UNIVERSITY OF FLORIDA · PI BARMPOUTIS, ANGELOS, OKUN, MICHAEL S · 2021 to 2025
$4.8M
Mobile Decision Support System for Nurse Management of Neuromodulation TherapyR01NR014852 · NINR · UNIVERSITY OF UTAH · PI BUTSON, CHRISTOPHER R, OKUN, MICHAEL S · 2015 to 2019
$2.9M
THE HUMAN THALAMOCORTICAL NETWORK IN TOURETTE SYNDROMER01NS096008 · NINDS · UNIVERSITY OF FLORIDA · PI GUNDUZ, AYSEGUL, OKUN, MICHAEL S · 2016 to 2020
$1.8M
University of Florida R25 Early Research Program for Neurology and Neurosurgery ResidentsR25NS108939 · NINDS · UNIVERSITY OF FLORIDA · PI HOH, BRIAN LIM, HOH, BRIAN LIM · 2019 to 2024
$537k
NINDS NIH HHS R01 NS096008NINDS NIH HHS R25 NS108939NINDS NIH HHS U01 NS119562NINDS NIH HHS UH3 NS119844NINR NIH HHS R01 NR014852
6 · The paper itself

Abstract

Introduction: Deep brain stimulation (DBS) is increasingly used to treat the symptoms of various neurologic and psychiatric conditions. People can undergo the procedure during reproductive years but the safety of DBS in pregnancy remains relatively unknown given the paucity of published cases. We thus conducted a review of the literature to determine the state of current knowledge about DBS in pregnancy and to determine how eligibility criteria are approached in clinical trials with respect to pregnancy and the potential for pregnancy. Methods: A literature review was conducted in EMBASE to identify articles involving DBS and pregnancy. Two reviewers independently analyzed the articles to confirm inclusion. Data extracted for analysis included conditions treated, complications at all stages of pregnancy, neonatal/pediatric outcomes, and DBS target. A second search was then conducted using www.clinicaltrials.gov. The same two reviewers then assessed whether each trial excluded pregnant individuals, lactating individuals, or persons of childbearing age planning to conceive. Also assessed was whether contraception had to be deemed adequate prior to enrollment. Results: The literature search returned 681 articles. Following independent analysis and agreement of two reviewers, 8 pregnancy related DBS articles were included for analysis. These articles described 27 subjects, 29 pregnancies (2 with subsequent pregnancies), and 31 infants (2 twin pregnancies). There was 1 preterm birth at 35 weeks, and 3 patients who experienced discomfort from the DBS battery (i.e., impulse generator) placement site. All 27 patients had a DBS device implanted before they became pregnant, which remained in use throughout their pregnancy. There was exclusion of pregnant individuals from 68% of 135 interventional trials involving DBS. Approximately 44% of these trials excluded persons of childbearing age not on "adequate contraception" or wishing to conceive in the coming years. Finally, 22% excluded breastfeeding persons. Conclusion: The data from 29 pregnancies receiving DBS treatment during pregnancy was not associated with unexpected pregnancy or post-partum complication patterns. Many clinical trials have excluded pregnant individuals. Documentation of outcomes in larger numbers of pregnancies will help clarify the safety profile and will help guide study designs that will safely include pregnant patients.

Indexed as

clinical trialsDBSdeep brain stimulationethicsneuromodulationpregnancysafety

Identifiers

PMID36248692
PMCPMC9557283

What Socratic 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 Socratic graph.