Noninvasive Cortical Neurostimulation For Diabetic Neuropathic Pain

NCT ID: NCT06152887

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-12-31

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.

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 (tDCS) in individuals with type 1 diabetes and painful polyneuropathy not responding adequately to traditional pharmacological pain treatment, in comparison to the effect of four weeks' sham treatment. Both treatments will be performed using a commercially available and validated device called Sooma tDCS. Sooma tDCS device is a non-invasive neurostimulator that has been CE-marked for the treatment of depression, chronic pain including neuropathic pain and fibromyalgia. The study will begin with a 2-week baseline registration period, in which the patients will receive no treatment. Next, the baseline period will be followed by a 4-week treatment period where the subjects will be randomized to either active treatment or sham treatment. Afterwards, a wash-out period of 6 weeks will occur. Finally, in the second treatment period the patients will switch in treatment assignment, meaning that patient who received active treatment will now receive sham treatment and vice versa. During both treatments, the patients will be asked to self-administer one stimulation dose daily, five times a week. During the whole study, subjects will be asked to complete a pain diary and several questionnaires. Moreover, at the beginning and end of each treatment period (four times), all subjects will undergo testing which will include brain magnetic resonance imaging (MRI) and quantitative sensory testing (QST). The primary efficacy parameters to be evaluated are short and longer lasting alleviation of clinical chronic pain and quality of life.

Conditions

Diabetic Neuropathy, Painful; Diabetes Mellitus, Type 1

Keywords

tDCS treatment; noninvasive cortical stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sooma Oy (tDCS), Helsinki, Finland

Intervention Type: 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)

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.

Group Type: SHAM_COMPARATOR

Sooma Oy (Sham), Helsinki, Finland

Intervention Type: 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.

Interventions

Sooma Oy (tDCS), Helsinki, Finland

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

Intervention Type: DEVICE

Sooma Oy (Sham), Helsinki, Finland

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.

Intervention Type: DEVICE

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Vissing fonden

UNKNOWN

Sponsor Role: collaborator

Jens Brøndum Frøkjær

OTHER

Sponsor Role: lead

Responsible Party

Jens Brøndum Frøkjær

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jens Brøndum Frøkjær, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Aalborg University Hospital

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jens Brøndum Frøkjær, MD, Ph.D

Role: CONTACT

Phone: 9766 5105

Email: jebf@rn.dk

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

Role: CONTACT

Phone: 9766 5119

Email: j.muthulingam@rn.dk

Facility Contacts

Jens Brøndum Frøkjær, MD, PhD

Role: primary

Janusiya Anajan, M.Sc, PhD

Role: backup

Other Identifiers

NOPAIN study

Identifier Type: -

Identifier Source: org_study_id