RecruitingEarly Phase 1NCT06603792

Neurofeedback for the Management of Neuropathic Pain in People with Diabetes


Sponsor

University of Southern Denmark

Enrollment

54 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 82 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called EEG-neurofeedback for people with neuropathy, painful diabetic. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 82 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEEG-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

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NCT06603792