Noninvasive Cortical Neurostimulation For Diabetic Neuropathic Pain
Launched by JENS BRØNDUM FRØKJÆR · Nov 29, 2023
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new method called transcranial direct current stimulation to see if it can help reduce pain and sensory issues in individuals with type 1 diabetes who have diabetic neuropathy. Diabetic neuropathy is a condition that causes pain and discomfort due to nerve damage from diabetes. The researchers want to find out if this noninvasive treatment can improve symptoms compared to a placebo treatment, which does not have any active ingredients.
To participate in this trial, individuals must be at least 18 years old, have type 1 diabetes, and be experiencing significant nerve pain. They will need to provide informed consent and meet certain health criteria, such as having a minimum level of pain. Participants will receive the stimulation treatment and will be monitored throughout the study. It’s important to note that people with certain medical conditions or those who cannot comply with the study procedures will not be eligible. This trial is actively recruiting participants and aims to offer new hope for managing diabetic neuropathy pain.
Gender
ALL
Eligibility criteria
- 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.)
About Jens Brøndum Frøkjær
Jens Brøndum Frøkjær is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in the pharmaceutical and biotechnology sectors, Frøkjær focuses on the development and oversight of innovative clinical trials that adhere to the highest ethical and scientific standards. His leadership is characterized by a collaborative approach, fostering partnerships with research institutions and healthcare professionals to drive the successful execution of trials. Through a rigorous commitment to quality and compliance, Jens Brøndum Frøkjær plays a pivotal role in bringing new therapies to market, ultimately enhancing the landscape of patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aalborg, , Denmark
Patients applied
Trial Officials
Jens Brøndum Frøkjær, MD, Ph.D
Principal Investigator
Professor and Chief Physician at Aalborg University Hospital, Department of Radiology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported