Actively Recruiting
Neurofeedback for the Management of Neuropathic Pain in People with Diabetes
Led by University of Southern Denmark · Updated on 2024-09-19
54
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
U
University of Southern Denmark
Lead Sponsor
E
European Foundation for the Study of Diabetes
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neurofeedback for the Management of Neuropathic Pain in People with Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 82 years
- Diagnosed with type 1 diabetes for at least 5 years or with type 2 diabetes
- Confirmed diagnosis of diabetic polyneuropathy (DPN) using Toronto consensus criteria and abnormal DPN Check
- Painful DPN defined by neuropathic pain grading system and IASP criteria
- Toronto Clinical Neuropathy Score (TCNS) greater than 5
- Pain intensity of at least 4 on an 11-point scale for at least 3 months, occurring at least semi-daily
- Stable pain medication regimen for more than 1 month prior to inclusion
You will not qualify if you...
- Presence of other neurological disorders (neurodegenerative diseases, migraine, epilepsy, stroke, tumor) or significant psychiatric illness
- Neuropathy or neuropathic pain caused by conditions other than diabetes (e.g., vitamin B12 deficiency, neurotoxic chemotherapy, chronic alcohol abuse, spinal stenosis)
- Changes in pain treatment during the study period (except paracetamol as rescue medication)
- Excessive alcohol use (more than 14 units/week for women or 21 units/week for men) or illegal substance abuse
- Positive pregnancy test
- Morphine use exceeding 20 mg per day
- Blindness or severe vision impairment
- Investigator judgment deeming participant unfit due to factors like substance use, mental incapacity, unwillingness, language barriers, or other concerns affecting study adherence
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Southern Denmark
Odense, Denmark, 5230
Actively Recruiting
Research Team
F
Francois Pouwer, Professor
CONTACT
J
Johanne Axelsen, PhD-student
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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