Noninvasive stimulation to relieve diabetic neuropathic pain
Treatment of Pain and Sensory Dysfunction in Diabetic Neuropathy by Brain Neuromodulation
This study is testing whether a noninvasive brain stimulation technique can help people with type 1 diabetes and painful nerve damage feel less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aalborg) |
| Trial ID | NCT06152887 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of transcranial direct current stimulation (tDCS) in alleviating pain and sensory disturbances in individuals with type 1 diabetes and painful peripheral neuropathy. It employs a randomized, cross-over design where participants will receive either active tDCS treatment or sham treatment over a four-week period, followed by a wash-out phase and a switch in treatment assignment. Participants will self-administer the stimulation daily and maintain a pain diary throughout the study. The aim is to determine if tDCS can provide significant pain relief compared to sham treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with type 1 diabetes and clinically established peripheral neuropathy experiencing neuropathic pain.
Not a fit: Patients with contraindications to MRI, major psychiatric disorders, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new non-pharmacological option for managing diabetic neuropathic pain.
How similar studies have performed: Other studies using tDCS for pain management have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Aalborg
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Jens Brøndum Frøkjær, MD, Ph.D — Professor and Chief Physician at Aalborg University Hospital, Department of Radiology
- Study coordinator: Jens Brøndum Frøkjær, MD, Ph.D
- Email: jebf@rn.dk
- Phone: 9766 5105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.