Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596681
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
A Study of the Safety and Tolerability of GA in the Treatment of Patients with Refractory Neuropathic Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Study of the Safety and Tolerability of GA in the Treatment of Patients with Refractory Neuropathic Pain
Status:
NOT_YET_RECRUITING
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:
Previous studies have shown that the anterior cingulate cortex is involved in the regulation of pain and its associated negative emotions that pyramidal neurons are highly excitable in chronic neuropathic pain conditions and that silencing of pyramidal neurons can eliminate pain The aim of this study was to evaluate the safety tolerability and efficacy of intracranial injection of GA containing the hM4Di gene in the anterior cingulate cortex in combination with oral clozapine for the treatment of refractory neuropathic pain
Detailed Description:
There is no effective treatment for refractory neuropathic pain and this study aims to develop new treatments Previous studies have shown that the anterior cingulate cortex is involved in the regulation of pain and its associated negative emotions that pyramidal neurons are highly excitable in chronic neuropathic pain conditions and that silencing of pyramidal neurons can eliminate pain Animal studies have shown that inhibition of anterior cingulate cortex neurons using chemical genetics can effectively eliminate pain responses Our team has obtained similar therapeutic effects with chemical genetics in mouse models of central pain bone cancer pain migraine and nerve injury In this study a chemogenetic approach was used to express designer receptors exclusively activated by designer drug hM4Di in the anterior cingulate cortex which binds to clozapine to inhibit neuronal excitability The aim of this study was to evaluate the safety tolerability and efficacy of intracranial injection of GA containing the hM4Di gene in the anterior cingulate cortex in combination with oral clozapine for the treatment of refractory neuropathic pain
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