NCT07432841 Personalized High-Definition tDCS Protocols for Chronic Pain Treatment
| NCT ID | NCT07432841 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2025-04-03 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2025-04-03 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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).
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT07432841 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07432841 currently recruiting?
Yes, NCT07432841 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istituti Clinici Scientifici Maugeri SpA to inquire about joining.
Where is the NCT07432841 trial being conducted?
This trial is being conducted at Milan, Italy, Palermo, Italy, Palermo, Italy, Pavia, Italy.
Who is sponsoring the NCT07432841 clinical trial?
NCT07432841 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The trial plans to enroll 144 participants.
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