Neurofeedback for the Management of Neuropathic Pain in People with Diabetes

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

June 30, 2026

Conditions
Neuropathy, Painful Diabetic
Interventions
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.

Trial Locations (1)

5230

RECRUITING

University of Southern Denmark, Odense

All Listed Sponsors
collaborator

European Foundation for the Study of Diabetes

OTHER

collaborator

Region of Southern Denmark

OTHER

collaborator

Vissing fonden

UNKNOWN

collaborator

Steno Diabetes Center Odense

OTHER

collaborator

Aarhus University Hospital

OTHER

lead

University of Southern Denmark

OTHER