Neurofeedback for the Management of Neuropathic Pain in People with Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 82
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Denmark
University of Southern Denmark
RECRUITING
Odense
Contact Information
Primary
Francois Pouwer, Professor
fpouwer@health.sdu.dk
+45 65 50 48 92
Backup
Johanne Axelsen, PhD-student
jlaxelsen@health.sdu.dk
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 54
Treatments
Experimental: Real EEG-neurofeedback
the NF intervention group will receive feedback based on the genuine real-time EEG activity
Sham_comparator: Sham EEG-neurofeedback
The sham-group will receive another participant's EEG-training protocol as a prerecorded signal. The feedback signal will consist of 15-25 rewards per minute. Meanwhile, the threshold for the sham group remains fixed, ensuring a consistent 70% positive feedback rate.
Related Therapeutic Areas
Sponsors
Collaborators: Region of Southern Denmark, Steno Diabetes Center Odense, Vissing fonden, European Foundation for the Study of Diabetes, Aarhus University Hospital
Leads: University of Southern Denmark

This content was sourced from clinicaltrials.gov