RECRUITINGEarly Phase 1INTERVENTIONAL

Neurofeedback for the Management of Neuropathic Pain in People with Diabetes

About This Trial

We will conduct a high-quality, blinded, randomized controlled trial (RCT) to rigorously test the effectiveness of EEG-based NF in patients with diabetes-related neuropathic pain in: 1) reducing pain intensity and pain affect, and 2) improving daily functioning and QoL.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

BEHAVIORAL

EEG-neurofeedback

Traditional neurofeedback uses one or two electrodes to modulate activity within a specific frequency band. Standardized Weighted Low Resolution Electromagnetic Tomography (swLORETA) analyzes the 3D distribution of intracortical brain electrical activity based on surface EEG recordings, enabling real-time brainwave imaging with a spatial resolution under one cubic centimeter. This divides the brain into over 12,000 voxels, offering localization similar to fMRI while maintaining EEG's faster temporal resolution. Source-localized NF can target specific, deeper brain regions, multiple Brodmann areas simultaneously, and provide feedback on connectivity between neural sources, enabling the training of specific neural networks. swLORETA metrics are compared to a normative database of neurotypical brains to produce z-scores for each area and metric. We will use the NeuroGuide normative database, FDA-approved and validated in peer-reviewed studies, widely used in clinical NF.

Locations (1)

University of Southern Denmark

Odense, Denmark