Short summary

Neuropathic pain is a common complication for people with diabetes. EEG-Neurofeedback is a promising pain reducing treatment. Using signals from their brain waves, the individual gets real- time feedback on a screen of changing visual material - depending on how the brain's electrical activity lowers or dampens towards the desired signals, and over 10 treatments patients will be taught to regulate relevant activity patterns themselves to reduce pain.

Rationale

There is a high demand for more effective, cheap treatments of painful DPN with no or minor side effects. This study has the potential to be a breakthrough in the treatment of DPN as it will test a new, relatively cheap and innovative treatment. If EEG-NF is found effective this will offer patients with painful DPN a new therapy, likely with minor side effects. Despite advances in understanding pain mechanisms, no new treatments for painful DPN have been made available over the past decades. This results in a low QoL for the patients with painful DPN. Again, there is therefore an urgent need to strengthen clinical multidisciplinary collaborations in an international manner to test innovative treatment strategies. This interdisciplinary, blinded, place-controlled, multicenter, international, phase II clinical trial is conducted by well-established research groups with experts within their respective fields, including psychology, neurology, neuroscience, endocrinology, and pain. If EEG-NF shows to be effective, it will be feasible to be implemented in the SDC and other relevant departments nationally and internationally.

Overall, we aim to determine the short term and long-term effects of EEG-NF compared with sham EEG-NF on self-reported pain, daily functioning and QoL in individuals with chronic painful DPN. Our hypothesis is that real EEG-NF will have significant short-term and long-term clinically meaningful pain reduction compared with sham EEG-NF.

Description of the cohort

54 participants with be recruited from Steno Diabetes Center Odense (SDCO), Steno Diabetes Center Aarhus (SDCA), and the Danish Pain Research Center in Aarhus. Participants will be people with diabetes and painful neuropathic pain for at least 6 months.

Data and biological material

Anthropometric measures:

height,

weight,

BMI,

hip- and waist circumference

Clinical information:

complete list of medication, status of other diseases, smoking status/accumulated tobacco exposure, weekly alcohol consumption, diabetes duration, allergies, prior history of ulcers on hand or leg, any symptoms of claudicatio intermittens)

Subjective symptoms of neuropathy and quality of life: Pain Disability Index (PDI), PROMIS, General QoL (WHOQOL-Bref), PCS, Brief pain inventory and will be introduced to the pain dairy with questions on sleep, pain intensity and affect

Nerve conduction measured by DPNCheck

Reflexes, vibration detection threshold (VDT), mechanical detection threshold (MDT), mechanical pain threshold (MPT), temperature sensation

Blood samples (analysed immediately and discarded

Collaborating researchers and departments

Steno Diabetes Center Odense, Odense University Hospital

• Knud Yderstræde

Steno Diabetes Center Aarhus, Aarhus University Hospital

• Christian Buhl

the Danish Pain Research Center, the Department of Clinical Medicine, Aarhus University and the Department of Neurology, Aarhus University Hospital

• Páll Karlsson