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NCT Number: NCT07835659

Retrospective Evaluation of Autonomic Activity Through Electrodermal Activity Measurement During Rehabilitation

Severe acquired brain injury (sABI) is a clinical condition characterized by brain damage severe enough to result in coma, with a worst Glasgow Coma Scale (GCS) score of ≤ 8 during the acute phase and a duration of more than 24 hours (Lavezzi et al., 2020). Acute brain injury may be traumatic, vascular, anoxic, metabolic, infectious, or tumor-related in origin and may result in complex neurological and multisystem sequelae. During the post-acute and rehabilitation phases, many patients present with altered levels of consciousness, reduced responsiveness to stimuli, cognitive and motor deficits, and often dysregulation of the autonomic nervous system (ANS). The ANS plays an essential role in modulating arousal, adaptation to environmental stimuli, and the response to stress, all of which are crucial to recovery processes and participation in rehabilitation interventions (Bodart et al., 2023).

Several lines of evidence indicate that autonomic dysfunction is common after severe brain injury. In patients with traumatic brain injury (TBI), for example, reduced electrodermal reactivity has been observed, together with less differentiated physiological responses to emotional or cognitive stimuli (Bodart et al.,2023). Likewise, in patients with severe disorders of consciousness (DoC), sympathovagal regulation is frequently impaired, with alterations in both baseline tone and responses to environmental changes (Reale et al., 2023). In this context, electrodermal activity (EDA) measurement represents a promising tool for assessing autonomic nervous system activity noninvasively and in real time. In the present study, the EmbracePlus EDA device (Empatica Inc., Cambridge, MA, USA), a wrist-worn device, was used in routine clinical practice. EDA directly reflects the activity of eccrine sweat glands, which are innervated by sympathetic cholinergic fibers, and is considered a sensitive indicator of physiological arousal, emotional processing, and cognitive load (Amin & Faghih, 2022; Zhu et al., 2024). Continuous recording of changes in skin conductance during clinical activities provides an opportunity to monitor autonomic responses even in patients whose behavioral manifestations are limited or absent. Recent studies have begun to explore the use of EDA in sABI populations. For example, exposure to an immersive virtual reality environment has been shown to produce a significant increase in sympathetic activity in patients with DoC (Reale et al., 2023), suggesting that the response to rehabilitation treatment may be associated with ANS responses. Other studies have investigated the relationship between EDA and dysautonomic phenomena such as paroxysmal sympathetic hyperactivity (PSH), showing that sudden changes in skin conductance may be associated with acute autonomic episodes in patients with severe TBI (Najda et al., 2025).

Despite growing interest in the use of EDA in neurology, the literature remains extremely limited regarding its use during conventional rehabilitation sessions. Most existing studies focus on controlled experimental protocols (e.g., visual, emotional, auditory, or virtual reality stimuli), whereas evidence is lacking on how the autonomic nervous system responds to different rehabilitation interventions during the rehabilitation pathway-whether motor, sensory, or cognitive-in patients with sABI. Given that rehabilitation success also depends on the patient's ability to maintain an adequate level of arousal and respond to therapeutic stimuli, objective assessment of autonomic activation could make an important contribution to the personalization of interventions.

A retrospective observational study based on EDA data collected during clinical practice represents a unique opportunity to provide information in this field. Analysis of electrodermal signals associated with different types of rehabilitation treatment may help to describe patterns of autonomic activation during different phases of the sessions, understand the relationship between physiological arousal and level of responsiveness, and provide an objective basis for modulating the intensity, duration, and modality of rehabilitation interventions in order to optimize patient engagement and response.

In light of these considerations, there is a clear need to improve understanding of ANS dynamics during post-acute rehabilitation in patients with severe acquired brain injury. The use of EDA as a physiological monitoring tool remains poorly explored in this setting, and a retrospective analysis of available data may represent an important first step toward the systematic integration of objective measures of autonomic arousal into routine rehabilitation practice.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented diagnosis of severe acquired brain injury.
  • Age ≥ 18 years.
  • At least one valid EDA recording collected during a rehabilitation session.

Exclusion criteria

  • Medical conditions that substantially alter sweating, sympathetic responses,
  • Patient's clinical instability (e.g., severe dysautonomia, extensive peripheral neuropathies, hemodynamic instability, sepsis).

Treatment and study plan

EmbracePlus EDA device

Device

In the present study, the EmbracePlus EDA device, a wrist-worn device, was used in routine clinical practice. EDA directly reflects the activity of eccrine sweat glands, which are innervated by sympathetic cholinergic fibers, and is considered a sensitive indicator of physiological arousal, emotional processing, and cognitive load

Primary outcomes

  1. EDA and rehabilitation

    Time frame: 4 mounts or maximum time of recovery

    To evaluate patterns of autonomic nervous system activation, measured by electrodermal activity (EDA), during different types of rehabilitation treatment.

Secondary outcomes

  1. EDA and clinical status

    Time frame: 4 mounts or maximum recovery time

    To explore the association between EDA parameters and the patient's clinical characteristics.

  2. EDA temporal pattern during rehabilitative session

    Time frame: 4 mounts or maximum recovery time

    Describe the temporal course of autonomic activation within a rehabilitation session

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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Registry information

Official study title

Retrospective Evaluation of Autonomic Activity Through Electrodermal Activity Measurement During Rehabilitation Treatment in Patients With Severe Acquired Brain Injury

Acronym: EDA-sABI

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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