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

NCT06306053 | Not Yet Recruiting DMC

• 1 other identifier: 2022/ST/217
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

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 (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.

Conditions

Pain

Keywords

neuromodulation; pain; telemonitoring; motor training; tDCS

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

  Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)

Secondary Outcomes (5)

• 12-item Short Form Survey (SF12)

  Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)

• Hospital Anxiety and Depression scale (HADS)

  Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)

• Brief Pain Inventory (BPI)

  Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)

• Pain Catastrophizing Scale (PCS)

  Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)

• Shared Decision-Making Questionnaire 9-Item (SDM-Q-9)

  Baseline (Day 1), after 1 week of treatment (Day 5), at the end of the treatment (Day 19), one month follow up (month 1), 3 months follow up (month 3)

Study Arms (3)

A Group

EXPERIMENTAL

Only tDCS treatment

Device: tDCS

B Group

ACTIVE COMPARATOR

Only Motor Training

Other: EuleriaLab

C Group

ACTIVE COMPARATOR

Both Treatment (tDCS+Motor Training)

Combination Product: tDCS+EuleriaLab

Interventions

tDCS+EuleriaLab COMBINATION_PRODUCT

Home based: Non invasive Neuromodulation treatment + Motor Training

C Group

tDCS DEVICE

Non invasive brain stimulation

A Group

EuleriaLab OTHER

Home Motor Training

B Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ASST Santi Paolo e Carlo: lead
• University of Milan: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Istituto Europeo di Oncologia: collaborator

Study Sites (3)

ASST-Santi Paolo e Carlo Hospital

Milan, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Istituto Europeo di Oncologia

Milan, Italy

Location

MeSH Terms

Conditions

Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Alberto Priori, PhD

  ASST-Santi Paolo e Carlo Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Priori, PhD

CONTACT

+390250323232; alberto.priori@unimi.it

Roberta Ferrucci, PhD

CONTACT

+390255033621; roberta.ferrucci@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: April 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (3)