Using transcranial direct-current stimulation to relieve cancer pain.
Efficacy Assessment of Transcranial Direct Current STIMulation (tDCS) in Reducing Pain in PALliative Cancer Patients.
This study is testing if a new treatment using mild electrical stimulation to the brain can help relieve severe cancer pain for patients in palliative care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 2 sites (Nantes and 1 other locations) |
| Trial ID | NCT04683172 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of transcranial direct-current stimulation (tDCS) as a treatment for refractory cancer pain in palliative care patients. Participants will receive 20 minutes of tDCS daily for five consecutive days, with one group receiving active stimulation and another receiving sham stimulation, ensuring blinding for both patients and investigators. The goal is to improve patients' quality of life and daily functioning, allowing them to return home under better conditions. The study aims to provide a new, bedside-appropriate treatment option for patients who often experience severe pain that is inadequately managed by traditional opioid therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with confirmed cancer at a palliative stage experiencing daily pain intensity of 4/10 or greater.
Not a fit: Patients with uncontrolled epilepsy, major depression, or those unable to self-assess pain will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and quality of life for patients with refractory cancer pain.
How similar studies have performed: While tDCS is a relatively novel approach in this context, preliminary studies have shown promise in using tDCS for pain management, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Patient with a confirmed cancer at a palliative stage 2. Pain whose mean intensity is greater than or equal to 4/10 in the 48 hours preceding inclusion 3. Pain present on a daily or almost daily basis (at least 4 days out of 7) 4. Pain that has been present for at least 48 hours before inclusion 5. Patients aged 18 or over 6. Patients who can be followed for the duration of the study (i.e. 3 weeks) 7. Patients affiliated to a health insurance plan or entitled 8. Life expectancy estimated at more than 3 weeks 9. Agreeing to participate in the study and having signed an informed consent Exclusion criteria 1. Inability to self-assess pain and complete self-questionnaires 2. History of head trauma or neurosurgical injury 3. Symptomatic intracranial hypertension (HTIC) 4. Uncontrolled epilepsy 5. Impossibility to correctly positioning the medical device 6. Abuse of drugs or psychoactive substances, at the discretion of the investigator 7. Current major depression or psychosis 8. Pregnant or breastfeeding woman 9. Patient already included in a research protocol on pain 10. Patient under legal protection 11. Absence of affiliation to a social security scheme 12. Specific contraindication to tDCS (intracerebral metal implant) 13. Patients deprived of liberty 14. Patients undergoing psychiatric care.
Where this trial is running
Nantes and 1 other locations
- Clinique Brétéché — Nantes, France (Recruiting)
- CHU Nantes — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Shahnaz KLOUCHE, MD
- Email: klouche@elsan.care
- Phone: (0)1 58 56 41 71
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.