Evidence map›Paper›PMID 28865495›Full record

Trial reportTrials2017

Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial.

Zhibao Mi, Kousick Biswas, J Kaci Fairchild, Anne Davis-Karim, Ciaran S Phibbs, Steven D Forman, Michael Thase, Gerald Georgette, Tamara Beale, David Pittman and 6 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01191333 (CSP #556 - The Effectiveness of rTMS in Depressed VA Patients), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
0.5field-weighted citation impact, top 29% 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.

NCT01191333 nacompletednot on this map

CSP #556 - The Effectiveness of rTMS in Depressed VA Patients

TypeinterventionalSponsorVA Office of Research and DevelopmentRan2012 to 2017Enrolled164ConditionsMajor Depressive DisorderArmsrTMS, Sham Device
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 20 citations in OpenAlex.

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  6. Predictors of response to accelerated rTMS in the treatment of treatment-resistant depression.European archives of psychiatry and clinical neuroscience · 2025
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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

16 authors at 7 institutions in 2 countries.

Zhibao MiDepartment of Veterans Affairs, Cooperative Studies Program Coordinating Center, Perry Point, MD, USA.
Kousick BiswasDepartment of Veterans Affairs, Cooperative Studies Program Coordinating Center, Perry Point, MD, USA.
J Kaci FairchildDepartment of Veterans Affairs, Sierra-Pacific MIRECC, and WRIISC, Palo Alto, CA, USA.
Anne Davis-KarimDepartment of Veterans Affairs, Cooperative Studies Program Pharmacy Coordinating Center, Albuquerque, NM, USA.
Ciaran S PhibbsDepartment of Veterans Affairs, Sierra-Pacific MIRECC, and WRIISC, Palo Alto, CA, USA.
Steven D FormanDepartment of Veterans Affairs, VA Medical Center, Pittsburgh, PA, USA.
Michael ThaseDepartment of Veterans Affairs, VA Medical Center, Philadelphia, PA, USA.
Gerald GeorgetteDepartment of Veterans Affairs, Sierra-Pacific MIRECC, and WRIISC, Palo Alto, CA, USA.
Tamara BealeDepartment of Veterans Affairs, Sierra-Pacific MIRECC, and WRIISC, Palo Alto, CA, USA.
David PittmanDepartment of Veterans Affairs, Cooperative Studies Program Pharmacy Coordinating Center, Albuquerque, NM, USA.
Margaret Windy McNerneyDepartment of Veterans Affairs, Sierra-Pacific MIRECC, and WRIISC, Palo Alto, CA, USA.
Allyson RosenDepartment of Veterans Affairs, Sierra-Pacific MIRECC, and WRIISC, Palo Alto, CA, USA.
Grant D HuangDepartment of Veterans Affairs, Cooperative Studies Program Central Office, Washington DC, USA.
Mark GeorgeDepartment of Veterans Affairs, Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
Art NodaDepartment of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.
Jerome A YesavageDepartment of Veterans Affairs, Sierra-Pacific MIRECC, and WRIISC, Palo Alto, CA, USA. yesavage@stanford.edu.ORCID 0000-0002-7390-3281
Mental Illness Research, Education and Clinical Centers · USThe Coordinating Center · USMedical University of South Carolina · USStanford Medicine · USStanford University · USUniversity of Pittsburgh · USVeterans Health Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvaluation of repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) in Veterans offers unique clinical trial challenges. Here we describe a randomized, double-blinded, intent-to-treat, two-arm, superiority parallel design, a multicenter study funded by the Cooperative Studies Program (CSP No. 556) of the US Department of Veterans Affairs.

methodsWe recruited medical providers with clinical expertise in treating TRMD at nine Veterans Affairs (VA) medical centers as the trial local investigators. We plan to enroll 360 Veterans diagnosed with TRMD at the nine VA medical centers over a 3-year period. We will randomize participants into a double-blinded clinical trial to left prefrontal rTMS treatment or to sham (control) rTMS treatment (180 participants each group) for up to 30 treatment sessions. All participants will meet Diagnostic and statistical manual of mental disorders, 4 DISCUSSION: The primary dependent measure will be remission rate (Hamilton Rating Scale for Depression (HRSD24) ≤ 10), and secondary analyses will be conducted on other indices. Comparisons between the rTMS and the sham groups will be made at the end of the acute treatment phase to test the primary hypothesis. The unique challenges to performing such a large technically challenging clinical trial with Veterans and potential avenues for improvement of the design in future trials will be described.

trial registrationClinicalTrials.gov, NCT01191333 . Registered on 26 August 2010. This report is based on the protocol version 4.6 amended in February 2016. All items from the World Health Organization Trial Registration Data Set are listed in Appendix A.

Indexed as

AffectTranscranial Direct Current StimulationClinical ProtocolsDepressive Disorder, Treatment-ResistantDouble-Blind MethodHumansMajor Depressive DisorderNeuropsychological TestsPrefrontal CortexRemission InductionResearch DesignSurveys and QuestionnairesTime FactorsTreatment OutcomeUnited StatesUnited States Department of Veterans AffairsHamilton Rating Scale for Depression (HRSD24)Repetitive transcranial magnetic stimulation (rTMS)Treatment-resistant major depression (TRMD)

Identifiers

PMID28865495
PMCPMC5581925
OpenAlexW2752522238

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.