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. 2022 Sep 29:16:997552.
doi: 10.3389/fnhum.2022.997552. eCollection 2022.

Safety of deep brain stimulation in pregnancy: A comprehensive review

Caroline King  1 , T Maxwell Parker  2 , Kay Roussos-Ross  1   3 , Adolfo Ramirez-Zamora  2 , John C Smulian  1   3 , Michael S Okun  2 , Joshua K Wong  2
Affiliations

Safety of deep brain stimulation in pregnancy: A comprehensive review

Caroline King et al. Front Hum Neurosci. .

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.

Keywords: DBS; clinical trials; deep brain stimulation; ethics; neuromodulation; pregnancy; safety.

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Conflict of interest statement

MO serves as Medical Advisor the Parkinson’s Foundation, and had received research grants from NIH, Parkinson’s Foundation, the Michael J. Fox Foundation, the Parkinson Alliance, Smallwood Foundation, the Bachmann-Strauss Foundation, the Tourette Syndrome Association, and the UF Foundation. MO’s research was supported by: NIH R01 NR014852, R01NS096008, UH3NS119844, and U01NS119562. MO had received royalties for publications with Demos, Manson, Amazon, Smashwords, Books4Patients, Perseus, Robert Rose, Oxford and Cambridge (movement disorders books). MO was an associate editor for New England Journal of Medicine Journal Watch Neurology and JAMA Neurology, and also participated in CME and educational activities (past 12–24 months) on movement disorders sponsored by WebMD/Medscape, RMEI Medical Education, American Academy of Neurology, Movement Disorders Society, and by Vanderbilt University. The institution and not MO receives grants from Medtronic, Abbvie, Boston Scientific, Abbott and Allergan, and the PI has no financial interest in these grants. MO had participated as a site PI and/or co-I for several NIH, foundation, and industry sponsored trials over the years but has not received honoraria. Research projects at the University of Florida receive device and drug donations. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
PRISMA 2020 flow diagram for systematic reviews detailing collection of data from EMBASE (left) and clinicaltrials.gov (right).
FIGURE 2
FIGURE 2
Figure displaying side effect profile found in a comprehensive literature review of pregnancy and Deep brain stimulation (DBS).
FIGURE 3
FIGURE 3
Flow diagram describing 2018 draft by FDA on the inclusion of pregnant persons in clinical trials. PD, Parkinson’s disease; OCD, obsessive-compulsive disorder; MDD, major depressive disorder; TS, Tourette’s syndrome.
See this image and copyright information in PMC

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