Neurofeedback for the Management of Neuropathic Pain in People with Diabetes

NCT06603792 | Recruiting Early Phase 1 DMC

• 1 other identifier: 11.719
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

We will conduct a high-quality, blinded, randomized controlled trial (RCT) to rigorously test the effectiveness of EEG-based NF in patients with diabetes-related neuropathic pain in: 1) reducing pain intensity and pain affect, and 2) improving daily functioning and QoL.

Conditions

Neuropathy, Painful Diabetic

Keywords

Neurofeedback; diabetic neuropathy; painful diabetic neuropathy; RCT; EEG-neurofeedback

Outcome Measures

Primary Outcomes (1)

• Pain intensity and affect

  Change in self-reported pain intensity and pain affect (an average over a daily measurement in a 7-day pain diary using a numeric rating scale (NRS) from 0-10)

  Before and after the intervention (approx. 8 weeks)

Secondary Outcomes (7)

• Neuropathic pain severity

  Before and after the intervention (approx. 8 weeks) and at 4 months follow-up (approx. a half year from start until four months follow up)

• Neuropathic pain severity

  Before and after the intervention (approx. 8 weeks) and at 4 months follow-up (approx. a half year from start until four months follow up)

• Neuropathic pain severity

  Before and after the intervention (approx. 8 weeks) and at 4 months follow-up (approx. a half year from start until four months follow up)

• Disability

  Before and after intervention (approx. 8 weeks). Between groups after intervention (approx. 8 weeks) and at 4 months follow-up (approx. a half year after baseline)

• Sleep quality

  7 day diary before baseline and after intervention (approx. 8 weeks)

Study Arms (2)

Real EEG-neurofeedback

EXPERIMENTAL

the NF intervention group will receive feedback based on the genuine real-time EEG activity

Behavioral: EEG-neurofeedback

Sham EEG-neurofeedback

SHAM COMPARATOR

The sham-group will receive another participant's EEG-training protocol as a prerecorded signal. The feedback signal will consist of 15-25 rewards per minute. Meanwhile, the threshold for the sham group remains fixed, ensuring a consistent 70% positive feedback rate.

Behavioral: EEG-neurofeedback

Interventions

EEG-neurofeedback BEHAVIORAL

Traditional neurofeedback uses one or two electrodes to modulate activity within a specific frequency band. Standardized Weighted Low Resolution Electromagnetic Tomography (swLORETA) analyzes the 3D distribution of intracortical brain electrical activity based on surface EEG recordings, enabling real-time brainwave imaging with a spatial resolution under one cubic centimeter. This divides the brain into over 12,000 voxels, offering localization similar to fMRI while maintaining EEG's faster temporal resolution. Source-localized NF can target specific, deeper brain regions, multiple Brodmann areas simultaneously, and provide feedback on connectivity between neural sources, enabling the training of specific neural networks. swLORETA metrics are compared to a normative database of neurotypical brains to produce z-scores for each area and metric. We will use the NeuroGuide normative database, FDA-approved and validated in peer-reviewed studies, widely used in clinical NF.

Real EEG-neurofeedback; Sham EEG-neurofeedback

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤82 years
• Diagnosed with 1) type 1 diabetes (for at least 5 years) or 2) type 2 diabetes
• The Toronto consensus criteria will be used for a case definition of DPN where patients have to have at least probable DPN (31). Diagnosis of DPN is confirmed with abnormal DPN Check. Painful DPN will be defined using the grading system for neuropathic pain (50) and will be in line with IASP's definition of neuropathic pain, i.e., "pain caused by a lesion or disease of the somatosensory system" (The Toronto consensus criteria).
• TCNS score \> 5
• Eligible patients with painful DPN must have a pain intensity of at least 4 on an 11-point numerical rating scale (NRS, 0-10) for at least 3 months on at least semi-daily basis and no severe pain other than pain due to neuropathy (the pain intensity will be based on the pain the patients experience while on current pain treatment, if any).

You may not qualify if:

• Concomitant neurological (neurodegenerative disorders, migraine, epilepsy, stroke, tumor) or clinically significant psychiatric illness
• Neuropathy or neuropathic pain due to other causes than diabetes (vitamin B12 deficiency, prior treatment with neurotoxic chemotherapy, chronic alcohol abuse, spinal stenosis, etc.)
• Change in current pain treatment during treatment (paracetamol is allowed as rescue medicine)
• Prior or current excessive alcohol use (\>14 or \>21 units/week for women and men, respectively) or illegal substance abuse
• Positive urine hCG test result indicating pregnancy
• Morphine use \>20mg/day
• Blindness or severely impaired vision
• The investigator finds the patient unfit for the study (e.g. due to use of alcohol or drugs, mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation or presence of any condition that in the investigators' opinion may lead to poor adherence to study protocol).

Sponsors & Collaborators

• University of Southern Denmark: lead
• European Foundation for the Study of Diabetes: collaborator
• Region of Southern Denmark: collaborator
• Vissing fonden: collaborator
• Steno Diabetes Center Odense: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

University of Southern Denmark

Odense, 5230, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Francois Pouwer, Professor

CONTACT

+45 65 50 48 92; fpouwer@health.sdu.dk

Johanne Axelsen, PhD-student

CONTACT

jlaxelsen@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The project will investigate two randomized groups: a 'true' EEG-NF-group and 'sham' EEG-NF-group.

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)