Pain in Neurorehabilitation Through Wearable Devices: an Exploratory Study

NCT05747040 | Unknown

• 1 other identifier: 001.2022.ISNB.NeuroRehab.MR-NR
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory interventional study aims at exploring the feasibility of using physiological signals recorded through wearable devices, together with artificial intelligence techniques, to assess pain automatically and objectively. Automatic methods to assess presence/absence of pain, discern nociceptive from neuropathic pain, and estimate the intensity of pain will be trained an tested on a population of multiple sclerosis patients undergoing neurorehabilitation.

Conditions

Pain; Multiple Sclerosis

Keywords

Pain assessment; physiological signals; wearable sensors; artificial intelligence; machine learning

Outcome Measures

Primary Outcomes (1)

• Number of registrations

  Number of concurrent physiological signal registrations and pain assessments through CRF monitoring questionnaire and CRF monitoring questionnaire-intervention. Diagnostic performance of the classifier (i.e., sensitivity, specificity, predictive value) against the gold standard (outcomes from CRF monitoring questionnaire and CRF monitoring questionnaire-intervention).

  The monitoring will be conducted during the intervention time frame [48 hours]

Secondary Outcomes (1)

• regression model - intensity of pain

  24 hours before and 24 hours after the treatment at the participant's home

Study Arms (1)

48-h monitoring

OTHER

The intervention consists of 48-h monitoring by using two types of monitoring: an objective monitoring, through a class IIa wearable medical device recording four physiological signals, and a subjective monitoring through a questionnaire developed with Microsoft Forms that can be compiled with a smartphone. The monitoring will be conducted during a motor neurorehabilitation treatment, 24 hours before and 24 hours after the treatment at the participant's home. Besides this monitoring, stratification questionnaires will be administered to each participant to be stratified in one of the three categories (absence of pain, nociceptive pain, or neuropathic pain) based on the following timeline: * t0: baseline * t1: pre-treatment * t2: post-treatment * t3: follow-up

Diagnostic Test: monitoring

Interventions

monitoring DIAGNOSTIC_TEST

The intervention consists of 48-h monitoring by using two types of monitoring: an objective monitoring, through a class IIa wearable medical device recording four physiological signals, and a subjective monitoring through a questionnaire developed with Microsoft Forms that can be compiled with a smartphone. The monitoring will be conducted during a motor neurorehabilitation treatment, 24 hours before and 24 hours after the treatment at the participant's home. Besides this monitoring, stratification questionnaires will be administered to each participant to be stratified in one of the three categories (absence of pain, nociceptive pain, or neuropathic pain) based on the following timeline: t0: baseline t1: pre-treatment t2: post-treatment t3: follow-up

48-h monitoring

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• Diagnosis of Multiple Sclerosis for at least three months post-onset
• Prescription of a physiotherapy-based motor rehabilitation program
• Signature of the informed consent to participate in the study

You may not qualify if:

• Heart rhythm modifying disease and/or factors such as arrhythmogenic heart disease (e.g., atrial fibrillation), presence of pacemakers and/or use of drugs capable of affecting heart rhythm, such as beta blockers (C07) or other antiarrhythmic drugs (C01)
• Cognitive impairments that preclude the possibility of providing valid informed consent, such as a disorder of consciousness or confusional state, the latter defined by temporal and/or spatial disorientation detected during ordinary conversation. In case of doubt, a simple confusional state assessment test (4AT) will be administered before enrollment
• Language comprehension skills lower than 75% in an ordinary conversation due to aphasic disorder of severe deafness despite the use of a hearing aid. In case of doubt, a simple language comprehension test (token test) will be administered before enrollment
• Linguistic expression less than 75%. In case of doubt, a simple verbal fluency test (verbal fluency by phonemic category) will be administered before enrollment
• Severe psychiatric comorbidity that may interfere with adherence to the study protocol (e.g., severe personality disorders, severe psychomotor agitation)
• History or current use of narcotic drugs (including marijuana)
• Modification in the two weeks prior to enrollment or foreseeable modification during enrollment of any chronic pain management program, both pharmacological (cortisone for systemic use, H02; antirheumatics, M01; analgesics, N02; antiepileptics, N03; antidepressants tricyclics, N06AA; atypical antidepressants such as duloxetine or venlafaxine, N06AX) and non-pharmacological (e.g., acupuncture or other manual therapies, physical therapies, such as tecar therapy)

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (1)

Irccs - Istituto Delle Scienze Neurologiche

Bologna, 40139, Italy

RECRUITING

Related Publications (1)

• Moscato S, Orlandi S, Di Gregorio F, Lullini G, Pozzi S, Sabattini L, Chiari L, La Porta F. Feasibility interventional study investigating PAIN in neurorehabilitation through wearabLE SensorS (PAINLESS): a study protocol. BMJ Open. 2023 Nov 22;13(11):e073534. doi: 10.1136/bmjopen-2023-073534.

  PMID: 37993169 DERIVED

MeSH Terms

Conditions

Pain; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Fabio La Porta

CONTACT

0516225851; fabio.laporta@isnb.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: February 28, 2023
• Study Start: February 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)