Personalized high-definition brain stimulation targeting the dACC for chronic pain
Innovative Neuromodulation Treatments for Chronic Pain: Assessing and Predicting the Effects of Personalized High-Definition Protocols for Transcranial Direct Current Stimulation (HD-tDCS)
This will try personalized high-definition transcranial direct current stimulation (HD-tDCS) aimed at the dorsal anterior cingulate cortex to reduce pain in adults with chronic pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 4 sites (Milan and 3 other locations) |
| Trial ID | NCT07432841 on ClinicalTrials.gov |
What this trial studies
The trial uses each participant's structural and functional MRI to create a personalized HD-tDCS montage targeting the dorsal anterior cingulate cortex (dACC). A total of 144 adults with chronic pain refractory to conservative and minimally invasive treatments will be randomized to receive five sessions in one week of anodal, cathodal, or sham HD-tDCS. High-definition montages are used to increase focality and intensity compared with conventional tDCS. Pain ratings and related clinical measures will be compared before and after the intensive treatment week.
Who should consider this trial
Good fit: Adults aged 18–75 with chronic pain for at least six months, average pain ≥4/10 despite conservative and minimally invasive treatments, who can undergo MRI/TMS and keep their pain medications stable for the study week.
Not a fit: Patients with seizure disorders, active malignancy, implanted head/neck devices or metallic implants, severe cognitive impairment, pregnancy, or MRI/TMS incompatibility are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce pain intensity for some patients and offer a targeted, noninvasive neuromodulation option.
How similar studies have performed: Conventional tDCS has shown mixed and generally modest benefits for chronic pain in previous studies, while personalized HD-tDCS targeting the dACC is a newer approach with limited direct clinical evidence to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan and 3 other locations
- University of Milano-Bicocca — Milan, Italy (Recruiting)
- Irccs Ismett — Palermo, Italy (Recruiting)
- University of Palermo — Palermo, Italy (Recruiting)
- Istituti Clinici Scientifici Maugeri Spa Società Benefit — Pavia, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.