Noninvasive Cortical Neurostimulation For Diabetic Neuropathic Pain

NCT06152887 | Unknown

• 1 other identifier: NOPAIN study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 of the CNS as compared to sham treatment.

Conditions

Diabetic Neuropathy, Painful; Diabetes Mellitus, Type 1

Keywords

tDCS treatment; noninvasive cortical stimulation

Outcome Measures

Primary Outcomes (1)

• Change in numeric rating scale (NRS) scores in pain diary

  The primary clinical efficacy parameter to be evaluated is pain relief. In the clinical part of the study the efficacy is assessed as changes in the daily experience of pain, which will be measured using a patient pain diary based on the NRS. Maximum intensity and average daily NRS will be recorded on daily basis. Minimum: 0 Maximum: 10

  20 weeks

Secondary Outcomes (5)

• Brief Pain Inventory questionnaire (mBPI)

  Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).

• Neuropathy Total Symptom Score-6 (NTSS-6)

  Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).

• Hospital Anxiety and Depression Scale (HADS)

  Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).

• Brain MRI

  Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).

• Quantitative sensory testing

  Baseline, week 4 (treatment I), week 10, week 14 (treatment II), week 18 (follow-up).

Study Arms (2)

Active tDCs

ACTIVE COMPARATOR

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.

Device: Sooma Oy (tDCS), Helsinki, Finland

Sham tDCS

SHAM COMPARATOR

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.

Device: Sooma Oy (Sham), Helsinki, Finland

Interventions

Sooma Oy (tDCS), Helsinki, Finland DEVICE

Using the 2-channel neuro-stimulator Sooma tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of the primary motor cortex (M1)

Active tDCs

Sooma Oy (Sham), Helsinki, Finland DEVICE

For the sham treatment, an electrical current will also be increased from 0 mA to 2 mA over the first 30 seconds, however, the current will be ramped back down to 0 mA after the initial ramp-up phase and no stimulation is delivered for the rest of the treatment.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Jens Brøndum Frøkjær: lead
• Novo Nordisk A/S: collaborator
• Vissing fonden: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus, Type 1

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jens Brøndum Frøkjær, MD, Ph.D

  Professor and Chief Physician at Aalborg University Hospital, Department of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Brøndum Frøkjær, MD, Ph.D

CONTACT

9766 5105; jebf@rn.dk

Janusiya Anajan Muthulingam, M.Sc., Ph.D

CONTACT

9766 5119; j.muthulingam@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: December 1, 2023
• Study Start: August 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

DK (1)