Using neurofeedback to manage diabetic neuropathic pain
Neurofeedback for the Management of Neuropathic Pain in People with Diabetes
EARLY_PHASE1 · University of Southern Denmark · NCT06603792
This study tests whether using brain training through neurofeedback can help people with diabetic neuropathic pain feel less pain and improve their quality of life.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 82 Years |
| Sex | All |
| Sponsor | University of Southern Denmark (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Odense) |
| Trial ID | NCT06603792 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of EEG-based neurofeedback in reducing pain intensity and improving quality of life for patients suffering from painful diabetic neuropathy. The study will involve a randomized controlled trial design with participants receiving either real neurofeedback or a sham treatment over 10 sessions. By providing real-time feedback on brain activity, the intervention seeks to empower patients to modulate their pain perception through learned techniques. This is the first rigorous investigation of neurofeedback for this specific condition, conducted as a triple-blind trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 82 with type 1 or type 2 diabetes who have been diagnosed with painful diabetic neuropathy.
Not a fit: Patients who do not have painful diabetic neuropathy or those with severe pain from other causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological treatment option for patients with painful diabetic neuropathy, potentially reducing their pain and improving daily functioning.
How similar studies have performed: While neurofeedback has shown promise in other contexts, this specific application for painful diabetic neuropathy is novel and has not been previously tested in a randomized controlled trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age ≥18 and ≤82 years * Diagnosed with 1) type 1 diabetes (for at least 5 years) or 2) type 2 diabetes * The Toronto consensus criteria will be used for a case definition of DPN where patients have to have at least probable DPN (31). Diagnosis of DPN is confirmed with abnormal DPN Check. Painful DPN will be defined using the grading system for neuropathic pain (50) and will be in line with IASP's definition of neuropathic pain, i.e., "pain caused by a lesion or disease of the somatosensory system" (The Toronto consensus criteria). * TCNS score \> 5 * Eligible patients with painful DPN must have a pain intensity of at least 4 on an 11-point numerical rating scale (NRS, 0-10) for at least 3 months on at least semi-daily basis and no severe pain other than pain due to neuropathy (the pain intensity will be based on the pain the patients experience while on current pain treatment, if any). * Stable pain medication for \> 1 month prior to inclusion. Exclusion criteria Exclusion Criteria: * Concomitant neurological (neurodegenerative disorders, migraine, epilepsy, stroke, tumor) or clinically significant psychiatric illness * Neuropathy or neuropathic pain due to other causes than diabetes (vitamin B12 deficiency, prior treatment with neurotoxic chemotherapy, chronic alcohol abuse, spinal stenosis, etc.) * Change in current pain treatment during treatment (paracetamol is allowed as rescue medicine) * Prior or current excessive alcohol use (\>14 or \>21 units/week for women and men, respectively) or illegal substance abuse * Positive urine hCG test result indicating pregnancy * Morphine use \>20mg/day * Blindness or severely impaired vision * The investigator finds the patient unfit for the study (e.g. due to use of alcohol or drugs, mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation or presence of any condition that in the investigators' opinion may lead to poor adherence to study protocol).
Where this trial is running
Odense
- University of Southern Denmark — Odense, Denmark (RECRUITING)
Study contacts
- Study coordinator: Francois Pouwer, Professor
- Email: fpouwer@health.sdu.dk
- Phone: +45 65 50 48 92
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.
Conditions: Neuropathy, Painful Diabetic, Neurofeedback, diabetic neuropathy, painful diabetic neuropathy, RCT, EEG-neurofeedback