Aquired Brain InjuryEDA-sABINCT07835659
Retrospective Evaluation of Autonomic Activity Through Electrodermal Activity Measurement During Rehabilitation
An observational study of Aquired Brain Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aquired Brain Injury
- What is being tested?
- EmbracePlus EDA device
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2026to 21 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Documented diagnosis of severe acquired brain injury.
- Age ≥ 18 years.
- At least one valid EDA recording collected during a rehabilitation session.
Who cannot join
- Medical conditions that substantially alter sweating, sympathetic responses,
- Patient's clinical instability (e.g., severe dysautonomia, extensive peripheral neuropathies, hemodynamic instability, sepsis).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Retrospective Evaluation of Autonomic Activity Through Electrodermal Activity Measurement During Rehabilitation Treatment in Patients With Severe Acquired Brain Injury
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.
Read more
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.
- Conditions
- Aquired Brain Injury
- Being tested
- EmbracePlus EDA device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbracePlus EDA deviceDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
EDA and rehabilitation
To evaluate patterns of autonomic nervous system activation, measured by electrodermal activity (EDA), during different types of rehabilitation treatment.
Measured: 4 months or maximum time of recovery
Secondary outcomes (3)
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.
Measured: 4 months or maximum recovery time
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).
Measured: 4 months or maximum recovery time
EDA temporal pattern during rehabilitative session
Describe the temporal course of autonomic activation within a rehabilitation session
Measured: 4 months or maximum recovery time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion21 Sep 2027 (estimated)
- Study completion21 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Augusto Fusco, Principal investigator, University Hospital Foundation "Agostino Gemelli" IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835659
- Sponsor's protocol ID
- 27214
- Acronym
- EDA-sABI
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 35900988Reale 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 38137708Bodart 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Autonomic Activity Through Electrodermal Activity Measurement During Rehabilitation Treatment in Patients With Severe Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT07835659
- Acronym / sponsor ID
- EDA-sABI / 27214
- Conditions
- Aquired Brain Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 21 Sep 2027 (estimated)
- Study completion
- 21 Sep 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Documented diagnosis of severe acquired brain injury.
- Age ≥ 18 years.
- At least one valid EDA recording collected during a rehabilitation session.
Key exclusion criteria (2 listed)
- Medical conditions that substantially alter sweating, sympathetic responses,
- Patient's clinical instability (e.g., severe dysautonomia, extensive peripheral neuropathies, hemodynamic instability, sepsis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmbracePlus EDA deviceIn 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 | Device | – |
Primary outcome
EDA and rehabilitation
Time frame: 4 months or maximum time of recovery
To evaluate patterns of autonomic nervous system activation, measured by electrodermal activity (EDA), during different types of rehabilitation treatment.
3 secondary outcomes
Number of Electrodermal Responses according to clinical characteristics
Time frame: 4 months or maximum recovery time
Amplitude of Electrodermal Responses according to clinical characteristics
Time frame: 4 months or maximum recovery time
EDA temporal pattern during rehabilitative session
Time frame: 4 months or maximum recovery time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Results publication: PubMed 35900988Amin 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.
- Results publication: PubMed 38137708Reale 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.
- Results publication: PubMed 36844281Bodart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Augusto Fusco principal investigator
University Hospital Foundation "Agostino Gemelli" IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Aquired Brain Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Augusto Fusco (+390630157281, augusto.fusco@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EDA and rehabilitation (time frame: 4 months or maximum time of recovery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07835659, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.