Noninvasive Cortical Neurostimulation For Diabetic Neuropathic Pain
Denmark40 participantsStarted 2023-08-01
Plain-language summary
To investigate whether transcranial direct current stimulation can alleviate pain and sensory related disturbances in individuals with type 1 diabetes and peripheral neuropathy through neuromodulation of the CNS as compared to sham treatment.
Who can participate
Age range18 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Minimum age of 18 years.
* Type-1 diabetes
* Clinically established peripheral neuropathy
* DN4 of ≥4 points indicating that the patient is suffering from neuropathic pain.
* NRS pain scores \>3
* Acceptable screening blood samples according to medical judgement
* Signed informed consent
Exclusion Criteria:
* Contraindications to MRI
* Not being able to understand Danish (written and/or verbally)
* Not being able to comply with the study procedures including home-treatment e.g., due to senile dementia, etc.
* Previous brain surgery
* Present alcohol or drug abuse
* Major mental and psychiatric disorders
* Pregnancy
* Active cancer-disease
* Known neural damage or disease in the neural system (e.g., MS or Guillain-Barre) other than diabetic neuropathy
* Previous chemotherapy or intake of experimental medicine
* Active herpes simplex virus or varicella zoster virus infection or known HIV
* Other reasons for limb pain (e.g., critical limb ischemia and lower back pain with radiating pain etc.)
What they're measuring
1
Change in numeric rating scale (NRS) scores in pain diary