ClinicalTrials.gg
Not yet recruitingNCT07835659EDA-sABIUpdated Sep 28, 2026

Retrospective Evaluation of Autonomic Activity Through Electrodermal Activity Measurement During Rehabilitation

An observational study in Aquired Brain Injury, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Updated Sep 28, 2026Results publication addedPrimary outcomes revisedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
72
Ages
18 Years and older
Sex
All
01

Study summary

Severe acquired brain injury (sABI) is a clinical condition characterised 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. Acute brain injury may be traumatic, vascular, anoxic, metabolic, infectious, or tumour-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, adapting to environmental stimuli, and responding to stress, all of which are crucial to recovery and participation in rehabilitation interventions.

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. 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. In this context, electrodermal activity (EDA) measurement is a promising tool for noninvasive, real-time assessment of autonomic nervous system activity. 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. Continuous recording of changes in skin conductance during clinical activities provides an opportunity to monitor autonomic responses even in patients whose behavioural 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, 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.

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 personalisation 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 to optimise 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.

02

Conditions studied

  • Aquired Brain Injury

Browse trials for

03

In context

Brain Injuries

946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.

This study's planned enrollment of 72 is below the median of 100 across 302 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients admitted to the High-Intensity Neurorehabilitation Unit during the observation period who underwent EDA monitoring at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, will be evaluated.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Medical conditions that substantially alter sweating, sympathetic responses,
  • Patient's clinical instability (e.g., severe dysautonomia, extensive peripheral neuropathies, hemodynamic instability, sepsis).
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
72 participants (estimated)
Patient registry
No

Interventions

  • DeviceEmbracePlus EDA 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

06

What researchers measure

Primary outcomes

  1. EDA and rehabilitation

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

    Time frame: 4 months or maximum time of recovery

Secondary outcomes

  1. Number of Electrodermal Responses according to clinical characteristics

    Number of electrodermal responses recorded during routine rehabilitation using the wrist-worn Empatica EmbracePlus device, evaluated according to the patient's clinical characteristics documented in the medical record. The measure is expressed as the number of electrodermal responses per rehabilitation session.

    Time frame: 4 months or maximum recovery time

  2. Amplitude of Electrodermal Responses according to clinical characteristics

    Amplitude of electrodermal responses recorded during routine rehabilitation using the wrist-worn Empatica Embrace Plus device, evaluated according to the patient's clinical characteristics documented in the medical record. Response amplitude is expressed in microsiemens (µS).

    Time frame: 4 months or maximum recovery time

  3. EDA temporal pattern during rehabilitative session

    Describe the temporal course of autonomic activation within a rehabilitation session

    Time frame: 4 months or maximum recovery time

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Amin R, Faghih RT. Physiological characterization of electrodermal activity enables scalable near real-time autonomic nervous system activation inference. PLoS Comput Biol. 2022 Jul 28;18(7):e1010275. doi: 10.1371/journal.pcbi.1010275. eCollection 2022 Jul. PubMed 35900988 ↗
  • Reale G, Fusco A, Calciano R, Vallario N, Vagnarelli G, Caliandro P, Castelli L, Moci M, Tieri G, Iasevoli L, Padua L. The Immediate Effects of Immersive Virtual Reality on Autonomic Nervous System Function in Patients with Disorders of Consciousness after Severe Acquired Brain Injury: A Pilot Study. J Clin Med. 2023 Dec 12;12(24):7639. doi: 10.3390/jcm12247639. PubMed 38137708 ↗
  • Bodart A, Invernizzi S, Lefebvre L, Rossignol M. Physiological reactivity at rest and in response to social or emotional stimuli after a traumatic brain injury: A systematic review. Front Psychol. 2023 Feb 10;14:930177. doi: 10.3389/fpsyg.2023.930177. eCollection 2023. PubMed 36844281 ↗
09

Updates

1 registry update since Sep 25, 2026
Primary outcomes
1 time frame changed
What changed in the outcomes
  • Time frameEDA and rehabilitation4 mounts or maximum time of recovery → 4 months or maximum time of recovery
Sep 28, 2026
Publications
Results publication added: Amin R, Faghih RT. Physiological characterization of electrodermal activity enables scalable near real-time autonomic nervous system activation inference. PLoS… PubMed 35900988 ↗; 2 more
Sep 28, 2026
Secondary outcomes
1 time frame changed, 2 added, 1 removed
What changed in the outcomes
  • AddedNumber of Electrodermal Responses according to clinical characteristicsTime frame: 4 months or maximum recovery time
  • AddedAmplitude of Electrodermal Responses according to clinical characteristicsTime frame: 4 months or maximum recovery time
  • RemovedEDA and clinical statusTime frame: 4 mounts or maximum recovery time
  • Time frameEDA temporal pattern during rehabilitative session4 mounts or maximum recovery time → 4 months or maximum recovery time
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Publications Results publication added: Amin R, Faghih RT. Physiological characterization of electrodermal activity enables scalable near real-time autonomic nervous system activation inference. PLoS… PubMed 35900988 ↗; 2 more
    Primary outcomes 1 time frame changed
    What changed in the outcomes
    • Time frameEDA and rehabilitation4 mounts or maximum time of recovery → 4 months or maximum time of recovery
    Secondary outcomes 1 time frame changed, 2 added, 1 removed
    What changed in the outcomes
    • AddedNumber of Electrodermal Responses according to clinical characteristicsTime frame: 4 months or maximum recovery time
    • AddedAmplitude of Electrodermal Responses according to clinical characteristicsTime frame: 4 months or maximum recovery time
    • RemovedEDA and clinical statusTime frame: 4 mounts or maximum recovery time
    • Time frameEDA temporal pattern during rehabilitative session4 mounts or maximum recovery time → 4 months or maximum recovery time
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07835659
Responsible party
Sponsor
First posted
Sep 23, 2026
Start date
Sep 21, 2026 (estimated)
Primary completion
Sep 21, 2027 (estimated)
Completion
Sep 21, 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Augusto Fusco
Contact
augusto.fusco@policlinicogemelli.it
+390630157281
Augusto Fusco
principal investigator · University Hospital Foundation "Agostino Gemelli" IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion