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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Psychological Assessment in Patients Treated with Spinal Cord Stimulation

NCT06761300

Spinal Cord Stimulation (SCS) Chronic Pain

RECRUITING

Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes

NCT01346202

Chronic Pain

COMPLETED

DEterminants of Decisional Autonomy In Chronic Pain Patients and Assessment of Treatment Effectiveness

NCT06811103

Chronic Pain

RECRUITING

Effects of Pain Neuroscience Education and Virtual Reality in Patients With Chronic Low Back Pain

NCT06410027

Chronic Low-back Pain

COMPLETED NA

The Influence of Interdisciplinary Multimodal Pain Therapy on Cerebral Connectivity in Chronic Pain Patients

NCT03634670

Chronic Pain, Interdisciplinary Multimodal Pain Therapy, Electroencephalography, Functional Connectivity

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A Group

Only tDCS treatment

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

Non invasive brain stimulation

B Group

Only Motor Training

Group Type ACTIVE_COMPARATOR

EuleriaLab

Intervention Type OTHER

Home Motor Training

C Group

Both Treatment (tDCS+Motor Training)

Group Type ACTIVE_COMPARATOR

tDCS+EuleriaLab

Intervention Type COMBINATION_PRODUCT

Home based: Non invasive Neuromodulation treatment + Motor Training

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tDCS+EuleriaLab

Home based: Non invasive Neuromodulation treatment + Motor Training

Intervention Type COMBINATION_PRODUCT

tDCS

Non invasive brain stimulation

Intervention Type DEVICE

EuleriaLab

Home Motor Training

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with chronic pain (Fibromyalgia, Headache, Oncological Pain)
* Age \> 18;
* Cognitive and motor skills sufficient to support a rehabilitation process mediated by an electronic device on a signed declaration by the clinician; -Having completed and signed the informed consent form, after a detailed explanation of the task and the tools used in the study.

Exclusion Criteria

* Have started new pharmacological treatments or have changed therapies that act on pain for less than a month;
* Have a brain stimulator, heart marrow stimulator or pumps for intrathecal drug delivery;
* Respiratory, cardiac, metabolic or other conditions incompatible with at least 30 minutes of light or moderate intensity exercise therapy;
* Aphasia, dementia, or psychiatric comorbidity interfering with communication or rehabilitation program compliance;
* Severe cognitive deficits;
* Blindness or severe vision problems which may interfere with the use of the tablet;
* Presence of cranial bone breaches;
* Recurrent seizures not being treated;
* Insufficient knowledge of the Italian language and/or inability to understand verbal and written instructions;
* Concomitant participation in another study or clinical trial involving rehabilitation therapy (recreational therapy, occupational therapy, physiotherapy) or administration of an investigational drug

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No