Evaluation of the Analgesic Effect of Direct Current Stimulation in the Treatment of Pelvic Pain, Comparing Three Groups: Trans-spinal Stimulation, Ganglionic Stimulation, and Placebo. A Randomized Double-blind Study
NCT ID: NCT07237165
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-12-01
2029-11-01
Brief Summary
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* Trans-spinal tsDCS stimulation,
* Ganglionic tsDCS stimulation,
* Placebo (sham) tsDCS stimulation.
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Detailed Description
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Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via Redcap. Only this physician will have the knowledge of the group allocated to the patient.
Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week.
Treatment sessions: after the baseline, sessions of neurostimulation will begin for 5 weeks.
After the end of neurostimulation sessions, patients will be followed for 2 weeks.
Throughout their participation in the study, patients will plot on a diary form their daily VNS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Trans-spinal stimulation
Non-invasive device-based neuromodulation
Direct current stimulation (tsDCS) protocol consist of one daily session for five consecutive days during the first week, followed by one session per week until week 5, after which the treatment period ends and post-treatment follow-up begins.
Dorsal root ganglion stimulation
Non-invasive device-based neuromodulation
Direct current stimulation (tsDCS) protocol consist of one daily session for five consecutive days during the first week, followed by one session per week until week 5, after which the treatment period ends and post-treatment follow-up begins.
Placebo (non-stimulation (sham) mode)
The device includes a non-stimulation (sham) mode, which can be activated while still placing the electrodes and setting up the device exactly as in the active condition. In this mode, no effective electrical current is delivered, but the procedure appears identical to the real stimulation. This allows the study to maintain double-blind conditions
Non-invasive device-based neuromodulation
Direct current stimulation (tsDCS) protocol consist of one daily session for five consecutive days during the first week, followed by one session per week until week 5, after which the treatment period ends and post-treatment follow-up begins.
Interventions
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Non-invasive device-based neuromodulation
Direct current stimulation (tsDCS) protocol consist of one daily session for five consecutive days during the first week, followed by one session per week until week 5, after which the treatment period ends and post-treatment follow-up begins.
Eligibility Criteria
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Inclusion Criteria
* Patient with stable ongoing medication (analgesic or otherwise) for at least one month.
* Patient for whom lack of response to conventional treatments has led the pain specialist or referring physician to consider non-pharmacological therapeutic options.
* Patient reporting a pain intensity score \>3 on the Numeric Visual Pain Scale (NVPS) during pre-screening.
* Patient affiliated with the national health insurance system or an equivalent scheme.
* Patient who has provided written informed consent.
Exclusion Criteria
* History of psychiatric disorders likely to interfere with the proper conduct of the study.
* Patient with skin lesions in the lumbar region.
* Person unable to understand the study protocol.
* Individuals covered by Articles L1121-5 to L1121-8 of the French Public Health Code, corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, individuals deprived of liberty by judicial or administrative decision, or under legal protection.
* Subject currently in the exclusion period of another clinical trial
18 Years
85 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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Clinical Neurophysiology Unit, Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Créteil, France
Créteil, , France
Pain Management Center, Grenoble Alpes University Hospital (CHU Grenoble Alpes)
Grenoble, , France
Countries
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Facility Contacts
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References
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Hodaj H, Payen JF, Lefaucheur JP. A Case of Long-Term Treatment of Chronic Pain Syndrome by Anodal tDCS of the Motor Cortex, Previously Resistant to High-Frequency rTMS and Implanted Spinal Cord Stimulation. Brain Stimul. 2016 Jul-Aug;9(4):618-20. doi: 10.1016/j.brs.2016.02.008. Epub 2016 Mar 22. No abstract available.
Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
Hodaj H, Payen JF, Mick G, Vercueil L, Hodaj E, Dumolard A, Noelle B, Delon-Martin C, Lefaucheur JP. Long-term prophylactic efficacy of transcranial direct current stimulation in chronic migraine. A randomised, patient-assessor blinded, sham-controlled trial. Brain Stimul. 2022 Mar-Apr;15(2):441-453. doi: 10.1016/j.brs.2022.02.012. Epub 2022 Feb 25.
Hodaj H, Payen JF, Hodaj E, Dumolard A, Maindet C, Cracowski JL, Delon-Martin C, Lefaucheur JP. Long-term treatment of chronic orofacial, pudendal, and central neuropathic limb pain with repetitive transcranial magnetic stimulation of the motor cortex. Clin Neurophysiol. 2020 Jul;131(7):1423-1432. doi: 10.1016/j.clinph.2020.03.022. Epub 2020 Apr 10.
Hodaj H, Payen JF, Dumolard A, Delon-Martin C, Lefaucheur JP. Treatment of pudendal neuralgia by high-frequency rTMS of the medial wall of motor cortex bilaterally using an angled figure-of-eight coil. Brain Stimul. 2020 Sep-Oct;13(5):1412-1413. doi: 10.1016/j.brs.2020.07.009. Epub 2020 Jul 23. No abstract available.
Hodaj H, Payen JF, Hodaj E, Sorel M, Dumolard A, Vercueil L, Delon-Martin C, Lefaucheur JP. Long-term analgesic effect of trans-spinal direct current stimulation compared to non-invasive motor cortex stimulation in complex regional pain syndrome. Brain Commun. 2023 Jul 1;5(4):fcad191. doi: 10.1093/braincomms/fcad191. eCollection 2023.
Guidetti M, Ferrucci R, Vergari M, Aglieco G, Naci A, Versace S, Pacheco-Barrios K, Giannoni-Luza S, Barbieri S, Priori A, Bocci T. Effects of Transcutaneous Spinal Direct Current Stimulation (tsDCS) in Patients With Chronic Pain: A Clinical and Neurophysiological Study. Front Neurol. 2021 Sep 6;12:695910. doi: 10.3389/fneur.2021.695910. eCollection 2021.
Rahman MA, Tharu NS, Gustin SM, Zheng YP, Alam M. Trans-Spinal Electrical Stimulation Therapy for Functional Rehabilitation after Spinal Cord Injury: Review. J Clin Med. 2022 Mar 11;11(6):1550. doi: 10.3390/jcm11061550.
Fregni F, El-Hagrassy MM, Pacheco-Barrios K, Carvalho S, Leite J, Simis M, Brunelin J, Nakamura-Palacios EM, Marangolo P, Venkatasubramanian G, San-Juan D, Caumo W, Bikson M, Brunoni AR; Neuromodulation Center Working Group. Evidence-Based Guidelines and Secondary Meta-Analysis for the Use of Transcranial Direct Current Stimulation in Neurological and Psychiatric Disorders. Int J Neuropsychopharmacol. 2021 Apr 21;24(4):256-313. doi: 10.1093/ijnp/pyaa051.
Pinto CB, Teixeira Costa B, Duarte D, Fregni F. Transcranial Direct Current Stimulation as a Therapeutic Tool for Chronic Pain. J ECT. 2018 Sep;34(3):e36-e50. doi: 10.1097/YCT.0000000000000518.
Truini A, Vergari M, Biasiotta A, La Cesa S, Gabriele M, Di Stefano G, Cambieri C, Cruccu G, Inghilleri M, Priori A. Transcutaneous spinal direct current stimulation inhibits nociceptive spinal pathway conduction and increases pain tolerance in humans. Eur J Pain. 2011 Nov;15(10):1023-7. doi: 10.1016/j.ejpain.2011.04.009. Epub 2011 May 14.
Cogiamanian F, Vergari M, Pulecchi F, Marceglia S, Priori A. Effect of spinal transcutaneous direct current stimulation on somatosensory evoked potentials in humans. Clin Neurophysiol. 2008 Nov;119(11):2636-40. doi: 10.1016/j.clinph.2008.07.249. Epub 2008 Sep 10.
Priori A, Ciocca M, Parazzini M, Vergari M, Ferrucci R. Transcranial cerebellar direct current stimulation and transcutaneous spinal cord direct current stimulation as innovative tools for neuroscientists. J Physiol. 2014 Aug 15;592(16):3345-69. doi: 10.1113/jphysiol.2013.270280. Epub 2014 Jun 6.
Cogiamanian F, Ardolino G, Vergari M, Ferrucci R, Ciocca M, Scelzo E, Barbieri S, Priori A. Transcutaneous spinal direct current stimulation. Front Psychiatry. 2012 Jul 4;3:63. doi: 10.3389/fpsyt.2012.00063. eCollection 2012.
Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.
Medeiros LF, de Souza IC, Vidor LP, de Souza A, Deitos A, Volz MS, Fregni F, Caumo W, Torres IL. Neurobiological effects of transcranial direct current stimulation: a review. Front Psychiatry. 2012 Dec 28;3:110. doi: 10.3389/fpsyt.2012.00110. eCollection 2012.
Margueritte F. Algies pelviennes chroniques : prévalence et caractéristiques associées dans la cohorte Constances. Revue d'Epidémiologie et de Santé Publique 2016, Doi : 10.1016/j.respe.2016.01.094
Rahman A, Reato D, Arlotti M, Gasca F, Datta A, Parra LC, Bikson M. Cellular effects of acute direct current stimulation: somatic and synaptic terminal effects. J Physiol. 2013 May 15;591(10):2563-78. doi: 10.1113/jphysiol.2012.247171. Epub 2013 Mar 11.
Other Identifiers
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38RC24.0366
Identifier Type: -
Identifier Source: org_study_id
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