Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152887
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-08-28
Brief Title:
Noninvasive Cortical Neurostimulation For Diabetic Neuropathic Pain
Sponsor:
Jens Brøndum Frøkjær
Organization:
Aalborg University Hospital
Study Overview
Official Title:
Treatment of Pain and Sensory Dysfunction in Diabetic Neuropathy by Brain Neuromodulation
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None