Chronic Pelvic PainSPINALSTIMNCT07237165
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
A study testing Non-invasive device-based neuromodulation in people with Chronic Pelvic Pain, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
The purpose of this study is to evaluate the analgesic effectiveness of direct current stimulation (tsDCS) in the treatment of pelvic pain by comparing three groups: Trans-spinal tsDCS stimulation, Ganglionic tsDCS stimulation, Placebo (sham) tsDCS stimulation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Non-invasive device-based neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2025to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 to 85 years, suffering from pelvic pain for more than one year (excluding musculoskeletal causes).
- 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.
Who cannot join
- History of drug addiction.
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Clinical Neurophysiology Unit, Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Créteil, France
Créteil
Pain Management Center, Grenoble Alpes University Hospital (CHU Grenoble Alpes)
Grenoble, 38043
Pr HODAJ HASAN, +334 76 76 75 75, HHodaj@chu-grenoble.fr
About this study
The purpose of this study is to evaluate the analgesic effectiveness of direct current stimulation (tsDCS) in the treatment of pelvic pain by comparing three groups:
- Trans-spinal tsDCS stimulation,
- Ganglionic tsDCS stimulation,
- Placebo (sham) tsDCS stimulation.
Read the detailed description
Conduct of study:
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
- Chronic Pelvic Pain
- Being tested
- Non-invasive device-based neuromodulation
- Keywords
- Chronic pelvic pain, Non-invasive spinal cord neuromodulation, Trans-spinal direct current stimulation (tsDCS), Trans-spinal stimulation, Dorsal root ganglion stimulation (DRGS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive device-based neuromodulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Trans-spinal stimulation | Active comparator | Not described Receives: Device: Non-invasive device-based neuromodulation |
| Dorsal root ganglion stimulation | Active comparator | Not described Receives: Device: Non-invasive device-based neuromodulation |
| Placebo (non-stimulation (sham) mode) | Placebo comparator | 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 Receives: Device: Non-invasive device-based neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of Pain
Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Pain Scale (VNPS): The patient will raise his pain level on a follow-up diary each day. The VNPS average will be calculated for each week. The VNS is a 10-point scale, ranging from 0 (worse) to 10 (better).
Measured: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)
Secondary outcomes (9)
Rate of Responding Patients
Patients will be classified as "responders" if they show a reduction in NVPS (Numeric Visual Pain Scale) scores equal to or greater than 30%
Measured: week 7 compared with baseline
Evaluation of the analgesic effect maintenance
Comparison between groups of the daily Numeric Visual Pain Scale (NVPS) values, averaged over 7 days
Measured: Between Week 5 (end of treatment) and Weeks 6 to 7 (post-treatment follow-up).
Assessment of Overall Patient Improvement.
Comparison between the 3 groups of the overall patient improvement using the Clinical Global Impression of Change scale (CGI).The CGI is a 7-point scale, ranging from 1 (better) to 7 (worse).
Measured: Day 50 from the beginning of tsDCS treatment compared to baseline
Quality of Life Improvement.
Comparison between the 3 groups of the improvement of quality of life using the SF12 (Short Form 12) questionnaire. SF12 includes a mental and social score ranging from 5.89 to 71.97 and a physical score ranging from 9.95 to 70. a high score indicates a better quality of life.
Measured: Day 50 from the beginning of tsDCS stimulation treatment compared to baseline
Evolution of Anxiety and Depressive Traits.
Comparison between the 3 groups of the improvement of anxiety and depressive traits using the HADS questionnaire (Hospital Anxiety and Depression Scale).the HADS score varies between 0 and 42. zero corresponding to the best score.
Measured: Day 50 from the beginning of tsDCS treatment compared to baseline
Evolution of Symptomatological Profiles of Neuropathic Pain.
Comparison between the 3 groups of symptomatological profiles of neuropathic pain using NPSI questionnaire (Neuropathic Pain Symptom Inventory).
Measured: Day 50 from the beginning of tsDCS treatment compared to baseline
Sympathetic Autonomic System Injury and Small Fiber Neuropathy.
Comparison between the 3 groups of sympathetic autonomic system injury and small fiber neuropathy using the Sudoscan® device.
Measured: Day 50 from the beginning of tsDCS treatment compared to baseline.
Autonomous System Assessement.
Comparison between the 3 groups of changes in skin tension and conductance during fMRI examination.
Measured: Day 50 from the beginning of tsDCS treatment compared to baseline.
Evolution of the use of analgesic treatments.
Comparison between the 3 groups of the evolution of the use of analgesic treatments reported on the diary.
Measured: From baseline to day 50.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237165
- Sponsor's protocol ID
- 38RC24.0366
- Acronym
- SPINALSTIM
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27101725Lefaucheur 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.
PubMed 27866120Hodaj 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.
PubMed 35219923Hodaj 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.
PubMed 32387962Hodaj 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.
PubMed 32712341Hodaj 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.
PubMed 37545548Guidetti 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.
PubMed 34552550Rahman 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.
PubMed 35329875Fregni 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.
PubMed 32710772Pinto 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.
PubMed 29952860Truini 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.
PubMed 21576030Cogiamanian 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.
PubMed 18786856Priori 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.
PubMed 24907311Cogiamanian 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.
PubMed 22783208Nitsche 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.
PubMed 11723286
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07237165
- Acronym / sponsor ID
- SPINALSTIM / 38RC24.0366
- Conditions
- Chronic Pelvic Pain
- Keywords
- Chronic pelvic pain, Non-invasive spinal cord neuromodulation, Trans-spinal direct current stimulation (tsDCS), Trans-spinal stimulation, Dorsal root ganglion stimulation (DRGS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the analgesic effectiveness of direct current stimulation (tsDCS) in the treatment of pelvic pain by comparing three groups:
- Trans-spinal tsDCS stimulation,
- Ganglionic tsDCS stimulation,
- Placebo (sham) tsDCS stimulation.
Detailed description
Conduct of study:
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trans-spinal stimulation | Active comparator | Device: Non-invasive device-based neuromodulation |
| Dorsal root ganglion stimulation | Active comparator | Device: Non-invasive device-based neuromodulation |
| Placebo (non-stimulation (sham) mode) | Placebo comparator | Device: Non-invasive device-based neuromodulationThe 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged 18 to 85 years, suffering from pelvic pain for more than one year (excluding musculoskeletal causes).
- 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.
Key exclusion criteria (6 listed)
- History of drug addiction.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive device-based neuromodulationDirect 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. | Device | Dorsal root ganglion stimulation, Placebo (non-stimulation (sham) mode), Trans-spinal stimulation |
Primary outcome
Evolution of Pain
Time frame: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)
Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Pain Scale (VNPS): The patient will raise his pain level on a follow-up diary each day. The VNPS average will be calculated for each week. The VNS is a 10-point scale, ranging from 0 (worse) to 10 (better).
9 secondary outcomes
Rate of Responding Patients
Time frame: week 7 compared with baseline
Evaluation of the analgesic effect maintenance
Time frame: Between Week 5 (end of treatment) and Weeks 6 to 7 (post-treatment follow-up).
Assessment of Overall Patient Improvement.
Time frame: Day 50 from the beginning of tsDCS treatment compared to baseline
Quality of Life Improvement.
Time frame: Day 50 from the beginning of tsDCS stimulation treatment compared to baseline
Evolution of Anxiety and Depressive Traits.
Time frame: Day 50 from the beginning of tsDCS treatment compared to baseline
Evolution of Symptomatological Profiles of Neuropathic Pain.
Time frame: Day 50 from the beginning of tsDCS treatment compared to baseline
Sympathetic Autonomic System Injury and Small Fiber Neuropathy.
Time frame: Day 50 from the beginning of tsDCS treatment compared to baseline.
Autonomous System Assessement.
Time frame: Day 50 from the beginning of tsDCS treatment compared to baseline.
Evolution of the use of analgesic treatments.
Time frame: From baseline to day 50.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 27101725Hodaj 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.
- Results publication: PubMed 27866120Lefaucheur 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.
- Results publication: PubMed 35219923Hodaj 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.
- Results publication: PubMed 32387962Hodaj 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.
- Results publication: PubMed 32712341Hodaj 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.
- Results publication: PubMed 37545548Hodaj 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.
- Results publication: PubMed 34552550Guidetti 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.
- Results publication: PubMed 35329875Rahman 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.
- Results publication: PubMed 32710772Fregni 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.
- Results publication: PubMed 29952860Pinto 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.
- Results publication: PubMed 21576030Truini 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.
- Results publication: PubMed 18786856Cogiamanian 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Pelvic Pain
Not yet recruiting
Focused Ultrasound Neuromodulation for Chronic Pain
Chronic Pain, Sickle Cell Disease
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
RecruitingObservational study
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Endometriosis
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruiting
Pregabalin for Chronic Pelvic Pain in Women
Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pain Management Center, Grenoble Alpes University Hospital (CHU Grenoble Alpes)
Grenoble, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive device-based neuromodulation in people with Chronic Pelvic Pain, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of Pain (time frame: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07237165, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.