Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577649
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Pain and Perceptual Distortion of Face
Sponsor:
None
Organization:
None
Study Overview
Official Title:
From Pain in the Face to Perceptual Distortion Exploring Mechanisms and Novel Treatment Strategies
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Post-traumatic trigeminal neuropathic pain PTNP is a unilateral or bilateral facial or oral pain following and caused by trauma to the trigeminal nerves with other symptoms andor clinical signs of trigeminal nerve dysfunction and persisting or recurring for more than 3 months PTNP may result from a major craniofacialoral trauma or may be subsequent to relatively minor dental treatments such as teeth extractions surgeries root canal treatment Patients suffering from this condition have a significantly reduced quality of life Unfortunately the currently available management modalities are associated with limited success and side effects
Repetitive transcranial magnetic stimulation rTMS which is a safe non-invasive brain stimulation technique has emerged as a potential treatment for chronic pain In this study the purpose is to explore the potential of rTMS in treating the persistent neuropathic pain by providing individualized treatment for the sufferers
Repetitive transcranial magnetic stimulation rTMS which is a safe non-invasive brain stimulation technique has emerged as a potential treatment for chronic pain In this study the purpose is to explore the potential of rTMS in treating the persistent neuropathic pain by providing individualized treatment for the sufferers
Detailed Description:
In addition to pain a curious observation in people with PTNP is that they report that the painful facial area is swollen or feels differently There are often no clinical signs or physical differences present hence such self-reported illusions may represent a kind of disrupted body image or a perceptual distortion of the face and can be speculated to contribute to the maintenance of facial pain rTMS paradigms are being widely applied in both therapeutic and investigative studiesIn this project the aim is to employ continuous theta-burst stimulation cTBS an inhibitory rTMS paradigm to evaluate its effect on pain perception and PD in people with PTNP
In this project people with PTNP N9 received a rTMS 50 Hz 600 pulses for 40s sessionweek as intervention for four consecutive weeks at the primary somatosensory cortex face area in a n-of-1 single-blinded randomized controlled cross-over design A active-sham-active-sham or B sham-active-sham-active That is the same participant received both active and sham either in the A order or B Pain intensity and perceptual distortion PD as perceived size changes of the affected face area were measured at baseline immediately 60 mins after rTMS in each session and end of the session a week after rTMS one and three months after rTMS Questionnaires on quality of life jaw function sleep quality were also assessed Changes in pain and PD after each intervention were evaluated
In this project people with PTNP N9 received a rTMS 50 Hz 600 pulses for 40s sessionweek as intervention for four consecutive weeks at the primary somatosensory cortex face area in a n-of-1 single-blinded randomized controlled cross-over design A active-sham-active-sham or B sham-active-sham-active That is the same participant received both active and sham either in the A order or B Pain intensity and perceptual distortion PD as perceived size changes of the affected face area were measured at baseline immediately 60 mins after rTMS in each session and end of the session a week after rTMS one and three months after rTMS Questionnaires on quality of life jaw function sleep quality were also assessed Changes in pain and PD after each intervention were evaluated
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