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NCT06306053Not yet recruiting

A New Treatment for Chronic Pain Combining Neuromodulation, Computer Assisted Training and Telemonitoring

A New Digital Technology-based Treatment for Chronic Pain Combining Neuromodulation, Computerassisted Training and Telemonitoring
ASST Santi Paolo e CarloClinicalTrials.govcombination product
Study focus
Disease/Condition
Pain
Drug/Device/Intervention
tDCS+EuleriaLab
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
ASST Santi Paolo e Carlo
Location
Milan,Milan,Milan, Italy
Timeline & enrollment
Phase
N/A
Start date
Apr 01, 2024
End date
Apr 30, 2026
Enrollment
126 participants
Primary outcome

Visual Analogue Scale (VAS)

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 (e.g. 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.

ICD-10 classifications
Pain, unspecifiedPain, not elsewhere classifiedPain in limbAcute painOther chronic pain
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06306053
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06306053 through Pure Global AI's free database. This phase not specified trial is sponsored by ASST Santi Paolo e Carlo and is currently Not yet recruiting. The study focuses on Pain. Target enrollment is 126 participants.

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