Chronic PainNCT07432841
Personalized High-Definition tDCS Protocols for Chronic Pain Treatment
A study testing Anodal High-Definition transcranial Direct Current Stimulation and Cathodal High-Definition transcranial Direct Current Stimulation in people with Chronic Pain, run by Istituti Clinici Scientifici Maugeri SpA at 4 sites in Italy.
Trial summary
This study aims to examine the use of neurostimulation as a potential adjuvant treatment for chronic pain. Among neurostimulation techniques, transcranial direct current stimulation (tDCS) represents a promising, yet not fully exploited, option. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Anodal High-Definition transcranial Direct Current Stimulation and Cathodal High-Definition transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 4 sitesItaly
- Study dates
- 3 Apr 2025to 31 May 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic pain lasting for at least six months
- Pain scores equal to or greater than 4 on Numerical Rating Scale (NRS) 0-10 on most days for the last 3 months
- Pain unresponsive to conservative treatment such as pharmacological therapy and physiotherapy, and unresponsive to minimally invasive treatments such as peripheral nerve blocks or neuromodulation or steroid epidural injections, when appropriate
- Age between 18 and 75
- Stable pain levels and willingness not to modify any ongoing pain management therapies during the study period (1 week)
Who cannot join
- History of seizure disorders
- Active malignancy
- Implanted medical devices and/or metallic implants in the head or neck region
- Cranial abnormalities
- Severe cognitive impairment (Montreal Cognitive Assessment (MoCA)<15.5)
- Neurological or psychiatric conditions, or significant comorbidities, that may interfere with tDCS
- Pregnancy
- Incompatibility with MRI and/or TMS
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
University of Milano-Bicocca
Milan, 20126
Leonor J Romero Lauro, +390264483794, leonor.romero1@unimib.it
- Recruiting
Irccs Ismett
Palermo, 90127
Vincenzina Lo Re, +390912192618, vlore@ismett.edu
- Recruiting
University of Palermo
Palermo, 90127
Massimiliano Oliveri, +3909123897736, massimiliano.oliveri@unipa.it
- Recruiting
Istituti Clinici Scientifici Maugeri Spa Società Benefit
Pavia, 27100
Nicola Canessa, +390382375845, nicola.canessa@iusspavia.it
Giulia C Mattavelli, +390382375845, giulia.mattavelli@iusspavia.it
About this study
Official title: Innovative Neuromodulation Treatments for Chronic Pain: Assessing and Predicting the Effects of Personalized High-Definition Protocols for Transcranial Direct Current Stimulation (HD-tDCS)
This study aims to examine the use of neurostimulation as a potential adjuvant treatment for chronic pain. Among neurostimulation techniques, transcranial direct current stimulation (tDCS) represents a promising, yet not fully exploited, option. Recent methodological advances allow for increased intensity and focality of its effects through personalized high-definition tDCS protocols (HD-tDCS), enabling targeted stimulation of specific brain regions involved in pain and analgesia processing, such as the dorsal anterior cingulate cortex (dACC).
Based on this evidence, the specific objective of the study is to investigate the effect of an innovative HD-tDCS protocol (personalized using structural and functional magnetic resonance imaging (fMRI)), with stimulation applied to the dACC. The experimental design involves randomly assigning 144 patients with chronic pain to three groups, who will undergo an intensive treatment (five sessions in the same week) with cathodal, anodal, or sham (placebo) HD-tDCS.
Read more
Patient recruitment and treatment will be equally distributed between sites located in Lombardy (IRCCS Maugeri-Pavia; University of Milano-Bicocca; n=72) and Palermo (IRCCS ISMETT-Palermo; University of Palermo; n=72).
The effects of neurostimulation will be: a) evaluated using self-reported measures of physical and social functioning (Brief Pain Inventory, BPI; primary outcome) before and after treatment, and at follow-up assessments at 3 weeks and 3 months; b) interpreted in relation to underlying neurophysiological changes, as revealed by the high spatial and temporal resolution provided, respectively, by fMR) and by transcranial magnetic stimulation-evoked potentials combined with electroencephalographic recording (TMS-EEG) before and after treatment (secondary outcome).
- Conditions
- Chronic Pain
- Being tested
- Anodal High-Definition transcranial Direct Current Stimulation, Cathodal High-Definition transcranial Direct Current Stimulation, Sham (No Treatment)
- Keywords
- Chronic pain, High-Definition transcranial Direct Current Stimulation, HD-tDCS, Magnetic Resonance Imaging, MRI, functional MRI, structural MRI, Transcranial Magnetic Stimulation, Electroencephalography, EEG, TMS-EEG, Randomized Controlled Trial, RCT
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal High-Definition transcranial Direct Current StimulationDevice
Participants will receive 5 stimulation sessions in a week, with the HD-tDCS setup including 6 electrodes (3 anode + 3 cathode electrodes) delivering a total current of 2mA. The spatial configuration of the six electrodes is aimed to induce the maximum intensity of stimulation at the target stereotactic coordinate, based on the modeling of estimated distribution of electric fields.
The active stimulation lasts for 20 minutes.
Cathodal High-Definition transcranial Direct Current StimulationDevice
Participants will receive 5 stimulation sessions in a week, with the HD-tDCS setup including 6 electrodes (3 anode + 3 cathode electrodes) delivering a total current of 2mA. The spatial configuration of the six electrodes is aimed to induce the maximum intensity of stimulation at the target stereotactic coordinate, based on the modeling of estimated distribution of electric fields.
The active stimulation lasts for 20 minutes. In cathodal sessions, polarity is reversed.
Sham (No Treatment)Device
Participants will receive 5 stimulation sessions in a week, with the HD-tDCS setup including 6 electrodes (3 anode + 3 cathode electrodes) delivering a total current of 2mA. The spatial configuration of the six electrodes is aimed to induce the maximum intensity of stimulation at the target stereotactic coordinate, based on the modeling of estimated distribution of electric fields. In sham sessions, the duration is also 20 minutes but participants are unaware that the stimulation intensity gradually ramps down to 0 mA after 30 seconds and then ramps up again during the final 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Cathodal | Active comparator | Cathodal HD-tDCS Receives: Device: Cathodal High-Definition transcranial Direct Current Stimulation |
| Anodal | Active comparator | Anodal HD-tDCS Receives: Device: Anodal High-Definition transcranial Direct Current Stimulation |
| Sham | Sham comparator | Sham HD-tDCS Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of perceived pain
We aim to assess the effect of a personalized (MRI-based) HD-tDCS protocol targeting dACC on clinical measures of perceived chronic pain. To this purpose, patients will be randomly assigned to 3 groups, each undergoing either cathodal, anodal or sham HD-tDCS treatment. Neurostimulation effects will be assessed with self-reported measures of perceived pain, collected via validated subjective functional questionnaires at 3 timepoints: before and after a 1-week (5 sessions) treatment, and at a 3 months follow-up assessment. The BPI score will be indeed considered the primary outcome measure for assessing the effect of HD-tDCS treatment, which will be deemed effective if a 30% reduction of pain intensity and interference on the BPI will be reached. The same statistical approach will be applied to the other clinical scales administered. In case of normality violations, data will be analyzed by means of non-parametric tests.
Measured: Baseline; Up to 3 weeks; After 3 months
Secondary outcomes (1)
Change in pain-related neural sensitivity measured with fMRI and TMS-EEG
Participants will undergo both fMRI and TMS-EEG sessions at the two main timepoints (pre- and post-treatment). For both techniques, data will be collected during a) resting-state (cross-fixation); b) observation of pain-related/unrelated facial expressions and bodily stimulations (Jauniaux et al., 2019). The T1-weighted MRI image collected on the pre-treatment session will be used for personalized targeting/modeling of HD-tDCS electric fields, and for neuronavigation in TMS-EEG sessions.
Measured: Baseline; Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start3 Apr 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca, IRCCS ISMETT Palermo, University of Palermo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432841
- Sponsor's protocol ID
- 37813/2024
- Other IDs
- PNRR-MCNT2-2023-12378259
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roth, Y., Padberg, F., and Zangen, A. (2007). Transcranial magnetic stimulation of deep brain regions: principles and methods. ADVANCES IN BIOLOGICAL PSYCHIATRY-BASEL-, 23(R), 204.
Garg, A., and Mago, V. (2021). Role of machine learning in medical research: A survey. Computer science review, 40, 100370.
Xiong HY, Cao YQ, Du SH, Yang QH, He SY, Wang XQ. Effects of High-Definition Transcranial Direct Current Stimulation Targeting the Anterior Cingulate Cortex on the Pain Thresholds: A Randomized Controlled Trial. Pain Med. 2023 Jan 4;24(1):89-98. doi: 10.1093/pm/pnac135.
PubMed 36066447Xiao X, Ding M, Zhang YQ. Role of the Anterior Cingulate Cortex in Translational Pain Research. Neurosci Bull. 2021 Mar;37(3):405-422. doi: 10.1007/s12264-020-00615-2. Epub 2021 Feb 10.
PubMed 33566301Wertli MM, Eugster R, Held U, Steurer J, Kofmehl R, Weiser S. Catastrophizing-a prognostic factor for outcome in patients with low back pain: a systematic review. Spine J. 2014 Nov 1;14(11):2639-57. doi: 10.1016/j.spinee.2014.03.003. Epub 2014 Mar 7.
PubMed 24607845Varoli E, Pisoni A, Mattavelli GC, Vergallito A, Gallucci A, Mauro LD, Rosanova M, Bolognini N, Vallar G, Romero Lauro LJ. Tracking the Effect of Cathodal Transcranial Direct Current Stimulation on Cortical Excitability and Connectivity by Means of TMS-EEG. Front Neurosci. 2018 May 15;12:319. doi: 10.3389/fnins.2018.00319. eCollection 2018.
PubMed 29867330Van Ryckeghem DML, Crombez G, Goubert L, De Houwer J, Onraedt T, Van Damme S. The predictive value of attentional bias towards pain-related information in chronic pain patients: a diary study. Pain. 2013 Mar;154(3):468-475. doi: 10.1016/j.pain.2012.12.008. Epub 2012 Dec 28.
PubMed 23375161Truini A, Aleksovska K, Anderson CC, Attal N, Baron R, Bennett DL, Bouhassira D, Cruccu G, Eisenberg E, Enax-Krumova E, Davis KD, Di Stefano G, Finnerup NB, Garcia-Larrea L, Hanafi I, Haroutounian S, Karlsson P, Rakusa M, Rice ASC, Sachau J, Smith BH, Sommer C, Tolle T, Valls-Sole J, Veluchamy A. Joint European Academy of Neurology-European Pain Federation-Neuropathic Pain Special Interest Group of the International Association for the Study of Pain guidelines on neuropathic pain assessment. Eur J Neurol. 2023 Aug;30(8):2177-2196. doi: 10.1111/ene.15831. Epub 2023 May 30.
PubMed 37253688Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain. 2019 Jan;160(1):19-27. doi: 10.1097/j.pain.0000000000001384.
PubMed 30586067Tetreault P, Mansour A, Vachon-Presseau E, Schnitzer TJ, Apkarian AV, Baliki MN. Brain Connectivity Predicts Placebo Response across Chronic Pain Clinical Trials. PLoS Biol. 2016 Oct 27;14(10):e1002570. doi: 10.1371/journal.pbio.1002570. eCollection 2016 Oct.
PubMed 27788130Romero Lauro LJ, Rosanova M, Mattavelli G, Convento S, Pisoni A, Opitz A, Bolognini N, Vallar G. TDCS increases cortical excitability: direct evidence from TMS-EEG. Cortex. 2014 Sep;58:99-111. doi: 10.1016/j.cortex.2014.05.003. Epub 2014 Jun 6.
PubMed 24998337Rogachov A, Cheng JC, Erpelding N, Hemington KS, Crawley AP, Davis KD. Regional brain signal variability: a novel indicator of pain sensitivity and coping. Pain. 2016 Nov;157(11):2483-2492. doi: 10.1097/j.pain.0000000000000665.
PubMed 27429176Pisoni A, Romero Lauro LJ, Vergallito A, Maddaluno O, Bolognini N. Cortical dynamics underpinning the self-other distinction of touch: A TMS-EEG study. Neuroimage. 2018 Sep;178:475-484. doi: 10.1016/j.neuroimage.2018.05.078. Epub 2018 May 31.
PubMed 29860085Perez-Borrego YA, Campolo M, Soto-Leon V, Rodriguez-Matas MJ, Ortega E, Oliviero A. Pain treatment using tDCS in a single patient: tele-medicine approach in non-invasive brain simulation. Brain Stimul. 2014 Mar-Apr;7(2):334-5. doi: 10.1016/j.brs.2013.11.008. Epub 2013 Dec 7. No abstract available.
PubMed 24389501Nguyen JP, Nizard J, Keravel Y, Lefaucheur JP. Invasive brain stimulation for the treatment of neuropathic pain. Nat Rev Neurol. 2011 Sep 20;7(12):699-709. doi: 10.1038/nrneurol.2011.138.
PubMed 21931348
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Neuromodulation Treatments for Chronic Pain: Assessing and Predicting the Effects of Personalized High-Definition Protocols for Transcranial Direct Current Stimulation (HD-tDCS)
- ClinicalTrials.gov ID
- NCT07432841
- Acronym / sponsor ID
- 37813/2024
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, High-Definition transcranial Direct Current Stimulation, HD-tDCS, Magnetic Resonance Imaging, MRI, functional MRI, structural MRI, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- University of Milano Bicocca, IRCCS ISMETT Palermo, University of Palermo
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 25 Feb 2026 (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.
This study aims to examine the use of neurostimulation as a potential adjuvant treatment for chronic pain. Among neurostimulation techniques, transcranial direct current stimulation (tDCS) represents a promising, yet not fully exploited, option. Recent methodological advances allow for increased intensity and focality of its effects through personalized high-definition tDCS protocols (HD-tDCS), enabling targeted stimulation of specific brain regions involved in pain and analgesia processing, such as the dorsal anterior cingulate cortex (dACC).
Based on this evidence, the specific objective of the study is to investigate the effect of an innovative HD-tDCS protocol (personalized using structural and functional magnetic resonance imaging (fMRI)), with stimulation applied to the dACC. The experimental design involves randomly assigning 144 patients with chronic pain to three groups, who will undergo an intensive treatment (five sessions in the same week) with cathodal, anodal, or sham (placebo) HD-tDCS.
Patient recruitment and treatment will be equally distributed between sites located in Lombardy (IRCCS Maugeri-Pavia; University of Milano-Bicocca; n=72) and Palermo (IRCCS ISMETT-Palermo; University of Palermo; n=72).
The effects of neurostimulation will be: a) evaluated using self-reported measures of physical and social functioning (Brief Pain Inventory, BPI; primary outcome) before and after treatment, and at follow-up assessments at 3 weeks and 3 months; b) interpreted in relation to underlying neurophysiological changes, as revealed by the high spatial and temporal resolution provided, respectively, by fMR) and by transcranial magnetic stimulation-evoked potentials combined with electroencephalographic recording (TMS-EEG) before and after treatment (secondary outcome).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cathodal | Active comparator | Device: Cathodal High-Definition transcranial Direct Current StimulationCathodal HD-tDCS |
| Anodal | Active comparator | Device: Anodal High-Definition transcranial Direct Current StimulationAnodal HD-tDCS |
| Sham | Sham comparator | Device: Sham (No Treatment)Sham HD-tDCS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of chronic pain lasting for at least six months
- Pain scores equal to or greater than 4 on Numerical Rating Scale (NRS) 0-10 on most days for the last 3 months
- Pain unresponsive to conservative treatment such as pharmacological therapy and physiotherapy, and unresponsive to minimally invasive treatments such as peripheral nerve blocks or neuromodulation or steroid epidural injections, when appropriate
- Age between 18 and 75
- Stable pain levels and willingness not to modify any ongoing pain management therapies during the study period (1 week)
Key exclusion criteria (8 listed)
- History of seizure disorders
- Active malignancy
- Implanted medical devices and/or metallic implants in the head or neck region
- Cranial abnormalities
- Severe cognitive impairment (Montreal Cognitive Assessment (MoCA)<15.5)
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 |
|---|---|---|
| Anodal High-Definition transcranial Direct Current StimulationParticipants will receive 5 stimulation sessions in a week, with the HD-tDCS setup including 6 electrodes (3 anode + 3 cathode electrodes) delivering a total current of 2mA. The spatial configuration of the six electrodes is aimed to induce the maximum intensity of stimulation at the target stereotactic coordinate, based on the modeling of estimated distribution of electric fields. The active stimulation lasts for 20 minutes. | Device | Anodal |
| Cathodal High-Definition transcranial Direct Current StimulationParticipants will receive 5 stimulation sessions in a week, with the HD-tDCS setup including 6 electrodes (3 anode + 3 cathode electrodes) delivering a total current of 2mA. The spatial configuration of the six electrodes is aimed to induce the maximum intensity of stimulation at the target stereotactic coordinate, based on the modeling of estimated distribution of electric fields. The active stimulation lasts for 20 minutes. In cathodal sessions, polarity is reversed. | Device | Cathodal |
| Sham (No Treatment)Participants will receive 5 stimulation sessions in a week, with the HD-tDCS setup including 6 electrodes (3 anode + 3 cathode electrodes) delivering a total current of 2mA. The spatial configuration of the six electrodes is aimed to induce the maximum intensity of stimulation at the target stereotactic coordinate, based on the modeling of estimated distribution of electric fields. In sham sessions, the duration is also 20 minutes but participants are unaware that the stimulation intensity gradually ramps down to 0 mA after 30 seconds and then ramps up again during the final 30 seconds. | Device | Sham |
Primary outcome
Reduction of perceived pain
Time frame: Baseline; Up to 3 weeks; After 3 months
We aim to assess the effect of a personalized (MRI-based) HD-tDCS protocol targeting dACC on clinical measures of perceived chronic pain. To this purpose, patients will be randomly assigned to 3 groups, each undergoing either cathodal, anodal or sham HD-tDCS treatment. Neurostimulation effects will be assessed with self-reported measures of perceived pain, collected via validated subjective functional questionnaires at 3 timepoints: before and after a 1-week (5 sessions) treatment, and at a 3 months follow-up assessment. The BPI score will be indeed considered the primary outcome measure for assessing the effect of HD-tDCS treatment, which will be deemed effective if a 30% reduction of pain intensity and interference on the BPI will be reached. The same statistical approach will be applied to the other clinical scales administered. In case of normality violations, data will be analyzed by means of non-parametric tests.
1 secondary outcome
Change in pain-related neural sensitivity measured with fMRI and TMS-EEG
Time frame: Baseline; Up to 3 weeks
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 25 Feb 2026.
- BackgroundRoth, Y., Padberg, F., and Zangen, A. (2007). Transcranial magnetic stimulation of deep brain regions: principles and methods. ADVANCES IN BIOLOGICAL PSYCHIATRY-BASEL-, 23(R), 204.
- BackgroundGarg, A., and Mago, V. (2021). Role of machine learning in medical research: A survey. Computer science review, 40, 100370.
- Background: PubMed 36066447Xiong HY, Cao YQ, Du SH, Yang QH, He SY, Wang XQ. Effects of High-Definition Transcranial Direct Current Stimulation Targeting the Anterior Cingulate Cortex on the Pain Thresholds: A Randomized Controlled Trial. Pain Med. 2023 Jan 4;24(1):89-98. doi: 10.1093/pm/pnac135.
- Background: PubMed 33566301Xiao X, Ding M, Zhang YQ. Role of the Anterior Cingulate Cortex in Translational Pain Research. Neurosci Bull. 2021 Mar;37(3):405-422. doi: 10.1007/s12264-020-00615-2. Epub 2021 Feb 10.
- Background: PubMed 24607845Wertli MM, Eugster R, Held U, Steurer J, Kofmehl R, Weiser S. Catastrophizing-a prognostic factor for outcome in patients with low back pain: a systematic review. Spine J. 2014 Nov 1;14(11):2639-57. doi: 10.1016/j.spinee.2014.03.003. Epub 2014 Mar 7.
- Background: PubMed 29867330Varoli E, Pisoni A, Mattavelli GC, Vergallito A, Gallucci A, Mauro LD, Rosanova M, Bolognini N, Vallar G, Romero Lauro LJ. Tracking the Effect of Cathodal Transcranial Direct Current Stimulation on Cortical Excitability and Connectivity by Means of TMS-EEG. Front Neurosci. 2018 May 15;12:319. doi: 10.3389/fnins.2018.00319. eCollection 2018.
- Background: PubMed 23375161Van Ryckeghem DML, Crombez G, Goubert L, De Houwer J, Onraedt T, Van Damme S. The predictive value of attentional bias towards pain-related information in chronic pain patients: a diary study. Pain. 2013 Mar;154(3):468-475. doi: 10.1016/j.pain.2012.12.008. Epub 2012 Dec 28.
- Background: PubMed 37253688Truini A, Aleksovska K, Anderson CC, Attal N, Baron R, Bennett DL, Bouhassira D, Cruccu G, Eisenberg E, Enax-Krumova E, Davis KD, Di Stefano G, Finnerup NB, Garcia-Larrea L, Hanafi I, Haroutounian S, Karlsson P, Rakusa M, Rice ASC, Sachau J, Smith BH, Sommer C, Tolle T, Valls-Sole J, Veluchamy A. Joint European Academy of Neurology-European Pain Federation-Neuropathic Pain Special Interest Group of the International Association for the Study of Pain guidelines on neuropathic pain assessment. Eur J Neurol. 2023 Aug;30(8):2177-2196. doi: 10.1111/ene.15831. Epub 2023 May 30.
- Background: PubMed 30586067Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain. 2019 Jan;160(1):19-27. doi: 10.1097/j.pain.0000000000001384.
- Background: PubMed 27788130Tetreault P, Mansour A, Vachon-Presseau E, Schnitzer TJ, Apkarian AV, Baliki MN. Brain Connectivity Predicts Placebo Response across Chronic Pain Clinical Trials. PLoS Biol. 2016 Oct 27;14(10):e1002570. doi: 10.1371/journal.pbio.1002570. eCollection 2016 Oct.
- Background: PubMed 24998337Romero Lauro LJ, Rosanova M, Mattavelli G, Convento S, Pisoni A, Opitz A, Bolognini N, Vallar G. TDCS increases cortical excitability: direct evidence from TMS-EEG. Cortex. 2014 Sep;58:99-111. doi: 10.1016/j.cortex.2014.05.003. Epub 2014 Jun 6.
- Background: PubMed 27429176Rogachov A, Cheng JC, Erpelding N, Hemington KS, Crawley AP, Davis KD. Regional brain signal variability: a novel indicator of pain sensitivity and coping. Pain. 2016 Nov;157(11):2483-2492. doi: 10.1097/j.pain.0000000000000665.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal High-Definition transcranial Direct Current Stimulation and Cathodal High-Definition transcranial Direct Current Stimulation in people with Chronic Pain, run by Istituti Clinici Scientifici Maugeri SpA at 4 sites in Italy.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
Reduction of perceived pain (time frame: Baseline; Up to 3 weeks; After 3 months). 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 NCT07432841, which also lists 43 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 25 Feb 2026.