Disorders of ConsciousnessPhase 1NCT03115021
Neurophysiological Effects of tPCS and tDCS on Patients With Disorders of Consciousness
A Phase 1 study testing Active tPCS and Active tDCS in people with Disorders of Consciousness, run by University of Liege at 1 site in Belgium.
Trial summary
This study aims at comparing the effects of transcranial direct current stimulation and transcranial pulsed current stimulation on neurophysiological outcomes on patients with disorders of consciousness. This study also aims to evaluate the effects of these techniques on patients' level of consciousness. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Disorders of Consciousness
- What is being tested?
- Active tPCS and Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2018to 30 Oct 2019
- Phase
- Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent in English or French
- Legally authorized surrogate available to provide informed consent
- History of non-traumatic brain injury with loss of consciousness caused by stroke, cerebral hemorrhage, hypoxic ischemic insult, metabolic disorder or infection.
- Has been followed clinically on the CRS-R for a minimum two weeks and has undergone a minimum of 4 assessments with the CRS-R.
- Serial CRS-R scores show at least one subscale on which there is no behavioral sign of conscious awareness (ie, command following, visual fixation or pursuit, object localization or recognition, localization to noxious stimulation, object manipulation, automatic motor responses, functional object use, discernable speech, discernable yes no communication, based on clinically obtained scores contained in the medical record).
- CRS-R screening examination completed by research staff confirms the absence of a behavioral sign of consciousness on a least one CRS-R subscale.
- Medically stable (i.e., no systemic illness or disease) and capable of independent ventilation
Who cannot join
- History of developmental, neurologic, or major psychiatric disorder resulting in functional disability up to time of enrollment.
- Evidence or surrogate report of uncontrolled seizure disorder
- Metallic brain implant or implanted electronic brain medical devices or pacemaker
- Subjects with craniectomy
- History of cranioplasty in the frontal region or recent cranioplasty that has not yet fully healed
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
This study aims at comparing the effects of transcranial direct current stimulation and transcranial pulsed current stimulation on neurophysiological outcomes on patients with disorders of consciousness. This study also aims to evaluate the effects of these techniques on patients' level of consciousness.
- Conditions
- Disorders of Consciousness
- Being tested
- Active tPCS, Active tDCS, Sham tPCS, Sham tDCS
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tPCSDevice
A current intensity of 2na and a stimulation frequency range of 6-10 Hz will be used with a peri-auricular ear-clip electrode montage for 20 minutes.
Active tDCSDevice
A current intensity of 2mA will be used for 20minutes. The electrodes that will be used will be standard sponge electrodes. The anode will be place over the left prefrontal cortex and the cathode over the right supraorbitofrontal area.
Sham tPCSDevice
Sham tPCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tPCS condition and the electrodes placement as well.
Sham tDCSDevice
Sham tDCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tDCS condition and the electrodes placement as well.
| Study group | Role | What they receive |
|---|---|---|
| Active tPCS / Sham tDCS | Experimental | All subject will receive active tPCS and sham tDCS for 20 minutes simultaneously. Receives: Device: Active tPCS; Device: Sham tDCS |
| Sham tPCS / Active tDCS | Experimental | All subject will receive sham tPCS and active tDCS for 20 minutes simultaneously. Receives: Device: Active tDCS; Device: Sham tPCS |
| Sham tPCS / Sham tDCS | Experimental | All subject will receive sham tPCS and sham tDCS for 20 minutes simultaneously. Receives: Device: Sham tPCS; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal coherence and EEG power as measured by Quantitative electroencephalographic analysis (qEEG)
EEG measures cortical electrical activity and examines the dynamic changes.
Measured: It will be measured over the course of about 3 weeks
Secondary outcomes (1)
Coma Recovery Scale Revised (CRS-R)
The CRS-R is a standard clinical protocol used to assess patients' level of consciousness. This test measures the level of response to sensory stimulation, ability to understand language and to communicate.
Measured: It will be measured over the course of about 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 May 2018
- Primary completion30 Sep 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurore Thibaut, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115021
- Sponsor's protocol ID
- 2016P001840
- Status last verified
- Oct 2021
- First submitted
- 11 Apr 2017
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Effects of tPCS and tDCS on Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT03115021
- Acronym / sponsor ID
- 2016P001840
- Conditions
- Disorders of Consciousness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 14 Apr 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.
This study aims at comparing the effects of transcranial direct current stimulation and transcranial pulsed current stimulation on neurophysiological outcomes on patients with disorders of consciousness. This study also aims to evaluate the effects of these techniques on patients' level of consciousness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active tPCS / Sham tDCS | Experimental | Device: Active tPCS, Device: Sham tDCSAll subject will receive active tPCS and sham tDCS for 20 minutes simultaneously. |
| Sham tPCS / Active tDCS | Experimental | Device: Active tDCS, Device: Sham tPCSAll subject will receive sham tPCS and active tDCS for 20 minutes simultaneously. |
| Sham tPCS / Sham tDCS | Experimental | Device: Sham tPCS, Device: Sham tDCSAll subject will receive sham tPCS and sham tDCS for 20 minutes simultaneously. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fluent in English or French
- Legally authorized surrogate available to provide informed consent
- History of non-traumatic brain injury with loss of consciousness caused by stroke, cerebral hemorrhage, hypoxic ischemic insult, metabolic disorder or infection.
- Has been followed clinically on the CRS-R for a minimum two weeks and has undergone a minimum of 4 assessments with the CRS-R.
- Serial CRS-R scores show at least one subscale on which there is no behavioral sign of conscious awareness (ie, command following, visual fixation or pursuit, object localization or recognition, localization to noxious stimulation, object manipulation, automatic motor responses, functional object use, discernable speech, discernable yes no communication, based on clinically obtained scores contained in the medical record).
Key exclusion criteria (6 listed)
- History of developmental, neurologic, or major psychiatric disorder resulting in functional disability up to time of enrollment.
- Evidence or surrogate report of uncontrolled seizure disorder
- Metallic brain implant or implanted electronic brain medical devices or pacemaker
- Subjects with craniectomy
- History of cranioplasty in the frontal region or recent cranioplasty that has not yet fully healed
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 |
|---|---|---|
| Active tPCSA current intensity of 2na and a stimulation frequency range of 6-10 Hz will be used with a peri-auricular ear-clip electrode montage for 20 minutes. | Device | Active tPCS / Sham tDCS |
| Active tDCSA current intensity of 2mA will be used for 20minutes. The electrodes that will be used will be standard sponge electrodes. The anode will be place over the left prefrontal cortex and the cathode over the right supraorbitofrontal area. | Device | Sham tPCS / Active tDCS |
| Sham tPCSSham tPCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tPCS condition and the electrodes placement as well. | Device | Sham tPCS / Active tDCS, Sham tPCS / Sham tDCS |
| Sham tDCSSham tDCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tDCS condition and the electrodes placement as well. | Device | Active tPCS / Sham tDCS, Sham tPCS / Sham tDCS |
Primary outcome
Signal coherence and EEG power as measured by Quantitative electroencephalographic analysis (qEEG)
Time frame: It will be measured over the course of about 3 weeks
EEG measures cortical electrical activity and examines the dynamic changes.
1 secondary outcome
Coma Recovery Scale Revised (CRS-R)
Time frame: It will be measured over the course of about 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Active tPCS and Active tDCS in people with Disorders of Consciousness, run by University of Liege at 1 site in Belgium.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 28 Oct 2021. 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 Belgium. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Signal coherence and EEG power as measured by Quantitative electroencephalographic analysis (qEEG) (time frame: It will be measured over the course of about 3 weeks). 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 28 Oct 2021.