Personalized High-Definition tDCS Protocols for Chronic Pain Treatment

NCT07432841 | Recruiting

• 2 other identifiers: 37813/2024PNRR-MCNT2-2023-12378259
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

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).

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; Electroencephalography; EEG; TMS-EEG; Randomized Controlled Trial; RCT

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline; Up to 3 weeks; After 3 months

Secondary Outcomes (1)

• Change in pain-related neural sensitivity measured with fMRI and TMS-EEG

  Baseline; Up to 3 weeks

Study Arms (3)

Cathodal

ACTIVE COMPARATOR

Cathodal HD-tDCS

Device: Cathodal High-Definition transcranial Direct Current Stimulation

Anodal

ACTIVE COMPARATOR

Anodal HD-tDCS

Device: Anodal High-Definition transcranial Direct Current Stimulation

Sham

SHAM COMPARATOR

Sham HD-tDCS

Device: Sham (No Treatment)

Interventions

Anodal High-Definition transcranial Direct Current Stimulation 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. The active stimulation lasts for 20 minutes.

Anodal

Cathodal High-Definition transcranial Direct Current Stimulation 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. The active stimulation lasts for 20 minutes. In cathodal sessions, polarity is reversed.

Cathodal

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.

Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• University of Milano Bicocca: collaborator
• IRCCS ISMETT Palermo: collaborator
• University of Palermo: collaborator

Study Sites (4)

University of Milano-Bicocca

Milan, 20126, Italy

RECRUITING

Irccs Ismett

Palermo, 90127, Italy

RECRUITING

University of Palermo

Palermo, 90127, Italy

RECRUITING

Istituti Clinici Scientifici Maugeri Spa Società Benefit

Pavia, 27100, Italy

RECRUITING

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MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 25, 2026
• Study Start: April 3, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

IT (4)