Evidence map›Paper›PMID 38123726›Full record

Trial reportMolecular psychiatry2024

Effect of non-invasive spinal cord stimulation in unmedicated adults with major depressive disorder: a pilot randomized controlled trial and induced current flow pattern.

Francisco Romo-Nava, Oluwole O Awosika, Ishita Basu, Thomas J Blom, Jeffrey Welge, Abhishek Datta, Alexander Guillen, Anna I Guerdjikova, David E Fleck, Georgi Georgiev and 7 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Molecular psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.1field-weighted citation impact, top 49% of its field
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.

NCT03433339 phase1 / phase2completednot on this map

Spinal Cord Stimulation for the Treatment of Major Depressive Disorder

TypeinterventionalSponsorUniversity of CincinnatiRan2018 to 2022Enrolled20ConditionsMajor Depressive DisorderArmsActive transcutaneous spinal direct current stimulation, Sham transcutaneous spinal direct current stimulation
NCT06795451 phase1 / phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains

TypeinterventionalSponsorUniversity of CincinnatiRan2025 to 2027Enrolled67ConditionsDepression - Major Depressive DisorderArmstranscutaneous spinal direct current stimulation
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Article
  2. 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

17 authors at 5 institutions in 2 countries.

Francisco Romo-NavaLindner Center of HOPE, Mason, OH, USA. romofo@ucmail.uc.edu.ORCID 0000-0002-5894-3701
Oluwole O AwosikaDepartment of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Ishita BasuDepartment of Neurosurgery, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Thomas J BlomLindner Center of HOPE, Mason, OH, USA.
Jeffrey WelgeDepartment of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Abhishek DattaResearch and Development, Soterix Medical, Inc, New York, NY, USA.
Alexander GuillenResearch and Development, Soterix Medical, Inc, New York, NY, USA.
Anna I GuerdjikovaLindner Center of HOPE, Mason, OH, USA.
David E FleckDepartment of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Georgi GeorgievLindner Center of HOPE, Mason, OH, USA.
Nicole MoriLindner Center of HOPE, Mason, OH, USA.
Luis R PatinoDepartment of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Melissa P DelBelloDepartment of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Robert K McNamaraDepartment of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Ruud M BuijsDepartamento de Fisiología Celular y Biología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, México City, México.ORCID 0000-0003-3894-4632
Mark A FryeDepartment of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0001-6997-4215
Susan L McElroyLindner Center of HOPE, Mason, OH, USA.
University of Cincinnati Medical Center · USLindner Center of HOPE · USSoterix Medical (United States) · USMayo Clinic · USUniversidad Nacional Autónoma de México · MX

Funding

LCenter for Clinical and Translational Science and TrainingUL1TR001425 · NCATS · UNIVERSITY OF CINCINNATI · PI HEUBI, JAMES E., KISSELA, BRETT M · 2015 to 2024
$37.5M
Virtual neuro-navigation system for personalized,community-based TMSR44MH126833 · NIMH · SOTERIX MEDICAL,INC. · PI TRUONG, DENNIS QUANGVINH · 2021 to 2023
$957k
The role of the circadian system in binge eating disorderK23MH120503 · NIMH · UNIVERSITY OF CINCINNATI · PI ROMO-NAVA, FRANCISCO · 2020 to 2023
$803k
Brain and Behavior Research Foundation (Brain & Behavior Research Foundation) 26649NCATS NIH HHS UL1 TR001425NIDA NIH HHS 75N95020C00024NIMH NIH HHS K23 MH120503NIMH NIH HHS R44 MH126833U.S. Department of Health & Human Services | NIH | National Institute of Mental Health (NIMH) K23MH120503
6 · The paper itself

Abstract

Converging theoretical frameworks suggest a role and a therapeutic potential for spinal interoceptive pathways in major depressive disorder (MDD). Here, we aimed to evaluate the antidepressant effects and tolerability of transcutaneous spinal direct current stimulation (tsDCS) in MDD. This was a double-blind, randomized, sham-controlled, parallel group, pilot clinical trial in unmedicated adults with moderate MDD. Twenty participants were randomly allocated (1:1 ratio) to receive "active" 2.5 mA or "sham" anodal tsDCS sessions with a thoracic (anode; T10)/right shoulder (cathode) electrode montage 3 times/week for 8 weeks. Change in depression severity (MADRS) scores (prespecified primary outcome) and secondary clinical outcomes were analyzed with ANOVA models. An E-Field model was generated using the active tsDCS parameters. Compared to sham (n = 9), the active tsDCS group (n = 10) showed a greater baseline to endpoint decrease in MADRS score with a large effect size (-14.6 ± 2.5 vs. -21.7 ± 2.3, p = 0.040, d = 0.86). Additionally, compared to sham, active tsDCS induced a greater decrease in MADRS "reported sadness" item (-1.8 ± 0.4 vs. -3.2 ± 0.4, p = 0.012), and a greater cumulative decrease in pre/post tsDCS session diastolic blood pressure change from baseline to endpoint (group difference: 7.9 ± 3.7 mmHg, p = 0.039). Statistical trends in the same direction were observed for MADRS "pessimistic thoughts" item and week-8 CGI-I scores. No group differences were observed in adverse events (AEs) and no serious AEs occurred. The current flow simulation showed electric field at strength within the neuromodulation range (max. ~0.45 V/m) reaching the thoracic spinal gray matter. The results from this pilot study suggest that tsDCS is feasible, well-tolerated, and shows therapeutic potential in MDD. This work also provides the initial framework for the cautious exploration of non-invasive spinal cord neuromodulation in the context of mental health research and therapeutics. The underlying mechanisms warrant further investigation. Clinicaltrials.gov registration: NCT03433339 URL: https://clinicaltrials.gov/ct2/show/NCT03433339 .

Indexed as

Major Depressive DisorderSpinal Cord StimulationAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPilot ProjectsTreatment Outcome

Identifiers

PMID38123726
PMCPMC11153138
OpenAlexW4390013217

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.