Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306053
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-04
Brief Title:
A New Treatment for Chronic Pain Combining Neuromodulation Computer Assisted Training and Telemonitoring
Sponsor:
ASST Santi Paolo e Carlo
Organization:
ASST Santi Paolo e Carlo
Study Overview
Official Title:
A New Digital Technology-based Treatment for Chronic Pain Combining Neuromodulation Computerassisted Training and Telemonitoring
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
TechNoPain
Brief Summary:
Chronic pain CP is a leading cause of medical disability healthcare expenditure and reduced psychological well-being Given the limited mobility travel burden and cost access to care can be problematic for patients suffering from this disease driving the recent shift toward care through telehealth programs Given the complex interrelationship of physical and psychosocial aspects related to chronic pain in this project the investigators propose to validate and investigate the effectiveness of new integrated health interventions by combining the technique of transcranial direct current stimulation tDCS complementary therapies and telemonitoring The investigators hypothesize that this novel combined approach will provide a more effective strategy to overcome the classic barriers of pharmacological treatments and access to healthcare due to lack of mobility To do this the investigators will rely on a previously developed integrated platform that enables effective delivery of non-pharmacological interventions and outcome assessment Many patients do not benefit from pharmacological and invasive treatments leading to the development of alternative therapeutic options such as non-invasive brain stimulation eg tDCS and complementary interventions to improve physical and psychological well-being These complementary interventions reduced pain intensity and psychological distress by improving individuals ability to manage and cope with their pain However due to the multiple co-occurring factors associated with chronic pain a multidisciplinary and integrated treatment approach is challenging Technology ecosystems can be a reliable tool to achieve such a diverse personalized approach and evaluate their results In a previous project the investigators developed PainRE-Life a dynamic and integrated technology ecosystem to enable continuity of care for CP patients including personalized applications training tools and telemonitoring tools for outcome assessment
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None