Treatment of Pain and Sensory Dysfunction in Diabetic Neuropathy by Brain Neuromodulation
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Contact Information
Primary
Jens Brøndum Frøkjær, MD, Ph.D
jebf@rn.dk
9766 5105
Backup
Janusiya Anajan Muthulingam, M.Sc., Ph.D
j.muthulingam@rn.dk
9766 5119
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Active_comparator: Active tDCs
Active tDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator. An anodal electrode is placed above the primary motor cortex, M1, while a cathode is placed above the contralateral supraorbital area.
Sham_comparator: Sham tDCS
Sham stimulation will be delivered to the motor cortex using a sham tDCS device that delivers a direct current for 30 seconds at the beginning and end of tDCS to provide sensory experiences similar to active stimulation.
Related Therapeutic Areas
Sponsors
Collaborators: Vissing fonden, Novo Nordisk A/S
Leads: Jens Brøndum Frøkjær