Pain Assessment in Neurorehabilitation Through Physiological Signals Recorded by Wearable Devices in Real-world Context: an Exploratory Study

Status unknownNot a drug-phase studyMS (type not specified)NCT05747040

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • monitoring

What it measured

Main measures

  • Number of registrations

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

    Pain

Other measures (1)

  • regression model - intensity of pain

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

    Pain

Who could take part

MS (type not specified) · 18 to 75

Show the full criteria

Inclusion criteria

* 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

Exclusion criteria

* 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)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Feb 2023

    2. Main results due

      Oct 2023

    3. Finished

      Oct 2023

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