Consciousness DisordersNCT03367078
tDCS in Patients With Disorder of Consciousness Due to Severe Acquired Brain Injury
An observational study of Consciousness Disorders and Brain Injuries, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
Trial summary
The present observational study is aimed at reporting the short-, mid- and long-term outcomes of patients with Disorder of Consciousness (DOC), in Vegetative State (VS) or Minimally Conscious State (MCS), due to a severe Acquired Brain Injury (sABI), after repeated treatments with anodal Transcranial Direct Current… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Consciousness Disorders, Brain Injuries, Vegetative State
- What is being tested?
- Anodal tDCS
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive DOC patients admitted to the sABI Operative Unit of the Montecatone Rehabilitation Institute
Who may be able to join
- patients with Disorder of Consciousness, VS (= LCF 2) or MCS (= LCF 3), due to sABI;
- any etiology, with the exception of extensive haemorrhagic lesions;
- stable clinical conditions.
Who cannot join
- presence of implanted devices (e.g. pacemakers, intrathecal infusers);
- presence of metallic brain implants (clips) or intracranial implants;
- presence of extensive craniotomy involving the area of application of tDCS;
- history of epileptic seizure;
- mechanical ventilation in place;
- history of psychotic disorders;
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- severe neurodegenerative pathology;
- pharmacotherapy with Na+ or Ca++ channel blockers (e.g. Carbamazepine) or with N-Methyl-D-aspartate (NMDA) receptor antagonists (e.g. Dextromethorphan);
- pregnancy in progress.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Use of Transcranial Direct Stimulation in Patients With Disorder of Consciousness, Due to Severe Acquired Brain Injury, to Stimulate Recovery of Consciousness
The present observational study is aimed at reporting the short-, mid- and long-term outcomes of patients with Disorder of Consciousness (DOC), in Vegetative State (VS) or Minimally Conscious State (MCS), due to a severe Acquired Brain Injury (sABI), after repeated treatments with anodal Transcranial Direct Current Stimulation (tDCS) on Left Dorsolateral Prefrontal Cortex (L-DLPFC), to stimulate recovery of consciousness. The results obtained will also be compared with those of a historical control cohort, before the introduction of tDCS, matched for demographic and clinical characteristics.
Read the detailed description
Patients surviving sABI resulting in a coma state, thanks to improvements in early intervention and intensive care technologies, in some cases begin to regain vigilance and consciousness within few weeks from the event. In other cases, however, while regaining vigilance, they may continue to present a DOC state. DOC patients, by definition, are unable to communicate and have severe motor, sensory and cognitive deficits. They can be in a Vegetative State (VS), characterized by wakefulness without consciousness, which can favorably evolve in a Minimally Conscious State (MCS).
Although there are currently no evidence-based guidelines on the treatment of DOC patients to facilitate their recovery of consciousness, several studies published in recent years have focused on various pharmacological and non-pharmacological interventions. Among these, there is a non-invasive stimulation technique, the Transcranial Direct Current Stimulation (tDCS), which has long been known for other indications. tDCS affects the neuronal membrane rest potential and is able to neuromodulate cortical excitability. Protocols in the literature describing the use of tDCS in DOC patients envisage anodal stimulation (active electrode) on the L-DLPFC area, with the reference electrode placed on a homologous controlateral area or on the controlateral shoulder. tDCS variants have also been described, both by type of current delivered and by active electrode's positioning, but they are still experimental.
The Montecatone Rehabilitation Institute (a 3rd level Italian hospital, specialized in intensive rehabilitation of sABI and spinal cord injured patients) has recently started adopting tDCS in clinical practice to stimulate recovery of consciousness of VS or MCS, post-sABI, patients. Since it was already known that a single tDCS applications is not sufficient to elicit detectable and durable responses, the Montecatone Institute's protocol envisages anode application on L-DLPFC area in a 20 minute daily session, possibly for 2 consecutive weeks (5 consecutive days per week). For a gradual and safe approach, 1 milliampere (mA) current intensity is applied during the first week, 2 mA during the second week.
The post-sABI DOC patients treated with tDCS at the Montecatone Institute, compared with the known literature, are more homogeneous with regard to the distance of time from the lesional event, moreover tDCS is administered at an earlier stage. The present observational, longitudinal study is aimed therefore at reporting the outcomes of such DOC patients treated with tDCS by evaluating them with functional and cognitive impairment scales, at short-term (at the conclusion of the first and second week of tDCS treatment), medium-term (3 months after the end of the treatment) and long-term (6 months after the end of the treatment). Electroencephalographic (EEG) pattern data will also be collected. The outcome data obtained will be compared with those of a historical control cohort too, matched for demographic and clinical characteristics. The present study aims at covering the lack in the literature of long-term follow-up data too.
It is expected that the results of the present study may be useful to provide concrete indications for planning further research studies aimed at evaluating the effectiveness of different techniques and/or protocols for application of tDCS in post-sABI DOC patients.
- Conditions
- Consciousness Disorders, Brain Injuries, Vegetative State, Minimally Conscious State, Cognitive Impairment
- Being tested
- Anodal tDCS, Usual care
- Keywords
- tDCS, transcranial direct current stimulation, acquired brain injury, coma, vigilance
- Medical subject headings
- Consciousness Disorders, Brain Injuries, Persistent Vegetative State, Cognitive Dysfunction, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
Anodal tDCS, on L-DLPFC area, is started 2 weeks after admission to the sABI Operative Unit with: one session per day (in the morning), possibly for 5 consecutive days per week (from Monday to Friday), for 2 consecutive weeks. Each tDCS session lasts 20 minutes. Current intensity is 1 mA during the first week, 2 mA in the second week
Usual careOther
Usual care of DOC patients
| Study group | Role | What they receive |
|---|---|---|
| tDCS cohort | DOC patients treated according to usual care, plus anodal tDCS (prospective cohort) Receives: Device: Anodal tDCS; Other: Usual care | |
| Historical control cohort | DOC patients treated according to usual care only (retrospective cohort of patients matched for demographic and clinical characteristics, admitted at the Montecatone Rehabilitation Institute no more than 3 years before the introduction of tDCS) Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in coma recovery in the tDCS cohort (short- and mid-term outcomes)
Assessment by Coma Recovery Scale-Revised (CRS-R) (on-line, where tDCS is administered)
Measured: Baseline (initial visit); tDCS session 5 (1 week); tDCS closing session 10 (2 weeks); follow-up 1 (1 week after tDCS closing session 10); follow-up 2 (3 months after tDCS closing session 10)
Change in cognitive functioning level in the tDCS cohort (short- and mid-term outcomes)
Assessment by Levels of Cognitive Functioning Scale (LCF) (off-line, i.e. where tDCS is administered, immediately after tDCS session)
Measured: Baseline (initial visit); tDCS session 5 (1 week); tDCS closing session 10 (2 weeks); follow-up 1 (1 week after tDCS closing session 10); follow-up 2 (3 months after tDCS closing session 10)
Secondary outcomes (7)
Change in coma recovery in the tDCS cohort (long-term outcome)
Assessment by CRS-R scale
Measured: Baseline (initial visit); follow-up 3 (6 months after tDCS closing session 10)
Change in cognitive functioning level in the tDCS cohort (long-term outcome)
Assessment by LCF scale
Measured: Baseline (initial visit); follow-up 3 (6 months after tDCS closing session 10)
Change in disability level in the tDCS cohort (short-, mid- and long-term follow-up)
Assessment by Rappaport's Disability Rating Scale (DRS)
Measured: Baseline (initial visit); follow-up 1 (1 week after tDCS closing session 10); follow-up 2 (3 months after tDCS closing session 10); follow-up 3 (6 months after closing session 10)
Change in electroencephalography pattern in the tDCS cohort
Assessment by electroencephalography (EEG) (off-line, i.e. where tDCS is administered, immediately after tDCS session)
Measured: Baseline (initial visit); tDCS tDCS closing session 10 (2 weeks)
Change in coma recovery between the tDCS cohort and the Historical control cohort
Assessment by CRS-R scale
Measured: Baseline (initial visit); 3 months; 6 months
Change in cognitive functioning level between the tDCS cohort and the Historical control cohort
Assessment by LCF scale
Measured: Baseline (initial visit); 3 months; 6 months
Change in disability level between the tDCS cohort and the Historical control cohort
Assessment by DRS scale
Measured: Baseline (initial visit); 3 months; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start18 Jun 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Organizational problems, change of research priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness DisordersStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Morreale, MD, Principal investigator, Montecatone Rehabilitation Institute S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367078
- Sponsor's protocol ID
- CE-17101
- Status last verified
- Aug 2020
- First submitted
- 4 Dec 2017
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Use of Transcranial Direct Stimulation in Patients With Disorder of Consciousness, Due to Severe Acquired Brain Injury, to Stimulate Recovery of Consciousness
- ClinicalTrials.gov ID
- NCT03367078
- Acronym / sponsor ID
- CE-17101
- Conditions
- Consciousness Disorders, Brain Injuries, Vegetative State, Minimally Conscious State, Cognitive Impairment
- Keywords
- tDCS, transcranial direct current stimulation, acquired brain injury, coma, vigilance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Organizational problems, change of research priorities
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.University, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 8 Dec 2017 (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.
The present observational study is aimed at reporting the short-, mid- and long-term outcomes of patients with Disorder of Consciousness (DOC), in Vegetative State (VS) or Minimally Conscious State (MCS), due to a severe Acquired Brain Injury (sABI), after repeated treatments with anodal Transcranial Direct Current Stimulation (tDCS) on Left Dorsolateral Prefrontal Cortex (L-DLPFC), to stimulate recovery of consciousness. The results obtained will also be compared with those of a historical control cohort, before the introduction of tDCS, matched for demographic and clinical characteristics.
Detailed description
Patients surviving sABI resulting in a coma state, thanks to improvements in early intervention and intensive care technologies, in some cases begin to regain vigilance and consciousness within few weeks from the event. In other cases, however, while regaining vigilance, they may continue to present a DOC state. DOC patients, by definition, are unable to communicate and have severe motor, sensory and cognitive deficits. They can be in a Vegetative State (VS), characterized by wakefulness without consciousness, which can favorably evolve in a Minimally Conscious State (MCS).
Although there are currently no evidence-based guidelines on the treatment of DOC patients to facilitate their recovery of consciousness, several studies published in recent years have focused on various pharmacological and non-pharmacological interventions. Among these, there is a non-invasive stimulation technique, the Transcranial Direct Current Stimulation (tDCS), which has long been known for other indications. tDCS affects the neuronal membrane rest potential and is able to neuromodulate cortical excitability. Protocols in the literature describing the use of tDCS in DOC patients envisage anodal stimulation (active electrode) on the L-DLPFC area, with the reference electrode placed on a homologous controlateral area or on the controlateral shoulder. tDCS variants have also been described, both by type of current delivered and by active electrode's positioning, but they are still experimental.
The Montecatone Rehabilitation Institute (a 3rd level Italian hospital, specialized in intensive rehabilitation of sABI and spinal cord injured patients) has recently started adopting tDCS in clinical practice to stimulate recovery of consciousness of VS or MCS, post-sABI, patients. Since it was already known that a single tDCS applications is not sufficient to elicit detectable and durable responses, the Montecatone Institute's protocol envisages anode application on L-DLPFC area in a 20 minute daily session, possibly for 2 consecutive weeks (5 consecutive days per week). For a gradual and safe approach, 1 milliampere (mA) current intensity is applied during the first week, 2 mA during the second week.
The post-sABI DOC patients treated with tDCS at the Montecatone Institute, compared with the known literature, are more homogeneous with regard to the distance of time from the lesional event, moreover tDCS is administered at an earlier stage. The present observational, longitudinal study is aimed therefore at reporting the outcomes of such DOC patients treated with tDCS by evaluating them with functional and cognitive impairment scales, at short-term (at the conclusion of the first and second week of tDCS treatment), medium-term (3 months after the end of the treatment) and long-term (6 months after the end of the treatment). Electroencephalographic (EEG) pattern data will also be collected. The outcome data obtained will be compared with those of a historical control cohort too, matched for demographic and clinical characteristics. The present study aims at covering the lack in the literature of long-term follow-up data too.
It is expected that the results of the present study may be useful to provide concrete indications for planning further research studies aimed at evaluating the effectiveness of different techniques and/or protocols for application of tDCS in post-sABI DOC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS cohort | – | Device: Anodal tDCS, Other: Usual careDOC patients treated according to usual care, plus anodal tDCS (prospective cohort) |
| Historical control cohort | – | Other: Usual careDOC patients treated according to usual care only (retrospective cohort of patients matched for demographic and clinical characteristics, admitted at the Montecatone Rehabilitation Institute no more than 3 years before the introduction of tDCS) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive DOC patients admitted to the sABI Operative Unit of the Montecatone Rehabilitation Institute
Key inclusion criteria (3 listed)
- patients with Disorder of Consciousness, VS (= LCF 2) or MCS (= LCF 3), due to sABI;
- any etiology, with the exception of extensive haemorrhagic lesions;
- stable clinical conditions.
Key exclusion criteria (9 listed)
- presence of implanted devices (e.g. pacemakers, intrathecal infusers);
- presence of metallic brain implants (clips) or intracranial implants;
- presence of extensive craniotomy involving the area of application of tDCS;
- history of epileptic seizure;
- mechanical ventilation in place;
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 |
|---|---|---|
| Anodal tDCSAnodal tDCS, on L-DLPFC area, is started 2 weeks after admission to the sABI Operative Unit with: one session per day (in the morning), possibly for 5 consecutive days per week (from Monday to Friday), for 2 consecutive weeks. Each tDCS session lasts 20 minutes. Current intensity is 1 mA during the first week, 2 mA in the second week | Device | tDCS cohort |
| Usual careUsual care of DOC patients | Other | Historical control cohort, tDCS cohort |
Primary outcome
Change in coma recovery in the tDCS cohort (short- and mid-term outcomes)
Time frame: Baseline (initial visit); tDCS session 5 (1 week); tDCS closing session 10 (2 weeks); follow-up 1 (1 week after tDCS closing session 10); follow-up 2 (3 months after tDCS closing session 10)
Assessment by Coma Recovery Scale-Revised (CRS-R) (on-line, where tDCS is administered)
Change in cognitive functioning level in the tDCS cohort (short- and mid-term outcomes)
Time frame: Baseline (initial visit); tDCS session 5 (1 week); tDCS closing session 10 (2 weeks); follow-up 1 (1 week after tDCS closing session 10); follow-up 2 (3 months after tDCS closing session 10)
Assessment by Levels of Cognitive Functioning Scale (LCF) (off-line, i.e. where tDCS is administered, immediately after tDCS session)
7 secondary outcomes
Change in coma recovery in the tDCS cohort (long-term outcome)
Time frame: Baseline (initial visit); follow-up 3 (6 months after tDCS closing session 10)
Change in cognitive functioning level in the tDCS cohort (long-term outcome)
Time frame: Baseline (initial visit); follow-up 3 (6 months after tDCS closing session 10)
Change in disability level in the tDCS cohort (short-, mid- and long-term follow-up)
Time frame: Baseline (initial visit); follow-up 1 (1 week after tDCS closing session 10); follow-up 2 (3 months after tDCS closing session 10); follow-up 3 (6 months after closing session 10)
Change in electroencephalography pattern in the tDCS cohort
Time frame: Baseline (initial visit); tDCS tDCS closing session 10 (2 weeks)
Change in coma recovery between the tDCS cohort and the Historical control cohort
Time frame: Baseline (initial visit); 3 months; 6 months
Change in cognitive functioning level between the tDCS cohort and the Historical control cohort
Time frame: Baseline (initial visit); 3 months; 6 months
Change in disability level between the tDCS cohort and the Historical control cohort
Time frame: Baseline (initial visit); 3 months; 6 months
Results and safety
The study was stopped early (reason given: Organizational problems, change of research priorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Angela Morreale, MD principal investigator
Montecatone Rehabilitation Institute S.p.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consciousness Disorders and Brain Injuries, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
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 9 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: stopped early, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Organizational problems, change of research priorities). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coma recovery in the tDCS cohort (short- and mid-term outcomes) (time frame: Baseline (initial visit); tDCS session 5 (1 week); tDCS closing session 10 (2 weeks); follow-up 1 (1 week after tDCS closing session 10); follow-up 2 (3 months after tDCS closing session 10)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2020.