Status:
UNKNOWN
Noninvasive Cortical Neurostimulation For Diabetic Neuropathic Pain
Lead Sponsor:
Jens Brøndum Frøkjær
Collaborating Sponsors:
Novo Nordisk A/S
Vissing fonden
Conditions:
Diabetic Neuropathy, Painful
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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...
Detailed Description
This study is a randomized, cross-over, controlled investigation. The overall objective of this study is to assess the pain-relieving effect of four weeks' transcranial direct current stimulation (tDC...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06152887
Start Date
August 1 2023
End Date
December 31 2025
Last Update
December 1 2023
Active Locations (1)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000