Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603792
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Neurofeedback for the Management of Neuropathic Pain in People with Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neurofeedback for the Management of Neuropathic Pain in People with Diabetes
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
20-40 of people with diabetes develop diabetic polyneuropathy DPN which often manifests as a painful complication strongly reducing quality of life Current standard pharmacological treatments for neuropathic pain are often ineffective and have considerable side effects Therefore there is an urgent need for better treatment options The way in which the brain interprets signals from the periphery can be modified through learning certain techniques which can enable patients to modify signals related to painful DPN and consequently experience pain alleviation Neurofeedback NF is a promising neuromodulatory therapy in which individuals receive real-time feedback about their brains neurophysiological signals thus increasing the volitional control of brain activity reducing the experience of pain Neurofeedback uses scalp EEG electrodes attached to a computer screen which give real-time feedback to the individual NF may offer symptom alleviation by teaching patients to regulate relevant activity patterns by themselves By rewarding the person whenever the neural activity changes in a desired direction the activity can be modulated NF has not yet been investigated in an RCT in people with painful DPN This proposed Danish-Brazilian project is the first triple blind RCT rigorously testing an EEG-NF intervention for neuropathic pain NP in diabetes The treatment will be conducted over 10 sessions in two randomized groups a real EEG-NF group and a sham placebo EEG-NF group Brazilian participants will also undergo functional magnetic resonance imaging fMRI scanning to investigate how the NF-treatment targets and alters neural mechanisms If found effective the low-cost EEG-NF can be made available and implemented at large scale for people with diabetes and painful neuropathy and will be in reach for low- to middle-income countries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None