Vegetative StateNCT01820923
Transcranial Brain Stimulation in Vegetative State Patients
A study testing Transcranial direct current stimulation (tDCS) and Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Vegetative State and Minimally Conscious State, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial summary
The aim of this study is to determine whether transcranial brain stimulations, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients in vegetative and minimally conscious state. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vegetative State, Minimally Conscious State
- What is being tested?
- Transcranial direct current stimulation (tDCS) and Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Dec 2014
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of vegetative state od minimally conscious state defined by the Disability Rating Scale with a score between 17 and 29.
- Age between 18 and 65 years.
- Time from the lesion: more than 4 months.
- Stable clinical condition.
- written consent fron the legal administrator of the patient.
Who cannot join
- Presence of epileptiform activity on EEG.
- Previous history of epilepsy.
- Extensive hemorrhage or ischemia.
- Metallic clips or intracranial implants.
- Pacemaker e Baclofen infusion.
- Presence of drugs influencing arousal or awareness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Use of Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation to Promote Diagnosis, Prognosis and Innovative Rehabilitation in Patients in Vegetative and Minimally Conscious State.
The aim of this study is to determine whether transcranial brain stimulations, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients in vegetative and minimally conscious state.
- Conditions
- Vegetative State, Minimally Conscious State
- Being tested
- Transcranial direct current stimulation (tDCS), Repetitive Transcranial Magnetic Stimulation (rTMS), Transcranial Direct Current Stimulation (SHAM), Repetitive Transcranial Magnetic Stimulation (SHAM)
- Medical subject headings
- Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Frequency of stimulation: 10Hz. Interstimulus interval: 1 min. Number of stimuli per session: 300. Number of sessions per week: 4 Total number of stimuli: 1.200
Transcranial Direct Current Stimulation (SHAM)Device
The electrodes of stimulation will be applied in the left fronto-temporal prefrontal cortex, but the device will be turned off.
Repetitive Transcranial Magnetic Stimulation (SHAM)Device
The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off.
| Study group | Role | What they receive |
|---|---|---|
| Brain stimulation | Experimental | Brain stimulation will consist of 4 types of intervention:
* real transcranial direct current stimulation (two weeks, five days a week)
* a week of wash-out
* Sham transcranial direct current stimulation (two weeks, five days a week)
* two weeks of wash-out
* real repetitive transcranial magnetic stimulation (two weeks, four days a week)
* a week of wash-out
* Sham repetitive transcranial magnetic stimulation (two weeks, three days a week)
Stimulations will be counterbalanced between patients. Receives: Device: Transcranial direct current stimulation (tDCS); Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (SHAM); Device: Repetitive Transcranial Magnetic Stimulation (SHAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG coherence analysis
EEG will be filtered between 0.5 and 30Hz by elliptic filters. Fast Fourier Transformation will be performed on 2 sec-epochs. For each stimulation site, coherence values will be estimated within four frequency bands: Delta (0.5-3.5 Hz), Theta (4-7.5 Hz), Alpha (8-12.5 Hz), and Beta (13-30 Hz). Each coherence map will be proportionally thresholded, preserving 50% of the strongest coherence values, to produce a weighted adjacency matrix. The estimated functional connectivity patterns will be characterized by means of two global network metrics derived from graph theory: modularity and global efficiency. Modularity measures how the network is organized into modules with high level clustering. Global efficiency measures how efficient the network is in exchanging information at the global level.
Measured: Change from baseline EEG coherence at the end of brain stimulation (two weeks)
Secondary outcomes (1)
Disability Rating Scale
Measured: Change from baseline DRS scale at the end of brain stimulation (two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vegetative StateStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianna Cavinato, IRCCS San Camillo, Venezia, Italy
- Investigators
- Francesco Piccione, MD, Study director, San Camillo Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820923
- Sponsor's protocol ID
- 2011.04
- Other IDs
- 288/08
- Status last verified
- Mar 2015
- First submitted
- 14 Mar 2013
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Giacino J, Fins JJ, Machado A, Schiff ND. Central thalamic deep brain stimulation to promote recovery from chronic posttraumatic minimally conscious state: challenges and opportunities. Neuromodulation. 2012 Jul;15(4):339-49. doi: 10.1111/j.1525-1403.2012.00458.x. Epub 2012 May 24.
PubMed 22624587Piccione F, Cavinato M, Manganotti P, Formaggio E, Storti SF, Battistin L, Cagnin A, Tonin P, Dam M. Behavioral and neurophysiological effects of repetitive transcranial magnetic stimulation on the minimally conscious state: a case study. Neurorehabil Neural Repair. 2011 Jan;25(1):98-102. doi: 10.1177/1545968310369802. Epub 2010 Jul 20.
PubMed 20647501
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Use of Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation to Promote Diagnosis, Prognosis and Innovative Rehabilitation in Patients in Vegetative and Minimally Conscious State.
- ClinicalTrials.gov ID
- NCT01820923
- Acronym / sponsor ID
- 2011.04
- Conditions
- Vegetative State, Minimally Conscious State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Mar 2013 (estimated)
- 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 aim of this study is to determine whether transcranial brain stimulations, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients in vegetative and minimally conscious state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain stimulation | Experimental | Device: Transcranial direct current stimulation (tDCS), Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Device: Transcranial Direct Current Stimulation (SHAM), Device: Repetitive Transcranial Magnetic Stimulation (SHAM)Brain stimulation will consist of 4 types of intervention: * real transcranial direct current stimulation (two weeks, five days a week) * a week of wash-out * Sham transcranial direct current stimulation (two weeks, five days a week) * two weeks of wash-out * real repetitive transcranial magnetic stimulation (two weeks, four days a week) * a week of wash-out * Sham repetitive transcranial magnetic stimulation (two weeks, three days a week) Stimulations will be counterbalanced between patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of vegetative state od minimally conscious state defined by the Disability Rating Scale with a score between 17 and 29.
- Age between 18 and 65 years.
- Time from the lesion: more than 4 months.
- Stable clinical condition.
- written consent fron the legal administrator of the patient.
Key exclusion criteria (6 listed)
- Presence of epileptiform activity on EEG.
- Previous history of epilepsy.
- Extensive hemorrhage or ischemia.
- Metallic clips or intracranial implants.
- Pacemaker e Baclofen infusion.
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 |
|---|---|---|
| Transcranial direct current stimulation (tDCS)2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex. | Device | Brain stimulation |
| Repetitive Transcranial Magnetic Stimulation (rTMS)Frequency of stimulation: 10Hz. Interstimulus interval: 1 min. Number of stimuli per session: 300. Number of sessions per week: 4 Total number of stimuli: 1.200 | Device | Brain stimulation |
| Transcranial Direct Current Stimulation (SHAM)The electrodes of stimulation will be applied in the left fronto-temporal prefrontal cortex, but the device will be turned off. | Device | Brain stimulation |
| Repetitive Transcranial Magnetic Stimulation (SHAM)The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off. | Device | Brain stimulation |
Primary outcome
EEG coherence analysis
Time frame: Change from baseline EEG coherence at the end of brain stimulation (two weeks)
EEG will be filtered between 0.5 and 30Hz by elliptic filters. Fast Fourier Transformation will be performed on 2 sec-epochs. For each stimulation site, coherence values will be estimated within four frequency bands: Delta (0.5-3.5 Hz), Theta (4-7.5 Hz), Alpha (8-12.5 Hz), and Beta (13-30 Hz). Each coherence map will be proportionally thresholded, preserving 50% of the strongest coherence values, to produce a weighted adjacency matrix. The estimated functional connectivity patterns will be characterized by means of two global network metrics derived from graph theory: modularity and global efficiency. Modularity measures how the network is organized into modules with high level clustering. Global efficiency measures how efficient the network is in exchanging information at the global level.
1 secondary outcome
Disability Rating Scale
Time frame: Change from baseline DRS scale at the end of brain stimulation (two 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 25 Mar 2015.
- Background: PubMed 22624587Giacino J, Fins JJ, Machado A, Schiff ND. Central thalamic deep brain stimulation to promote recovery from chronic posttraumatic minimally conscious state: challenges and opportunities. Neuromodulation. 2012 Jul;15(4):339-49. doi: 10.1111/j.1525-1403.2012.00458.x. Epub 2012 May 24.
- Results publication: PubMed 20647501Piccione F, Cavinato M, Manganotti P, Formaggio E, Storti SF, Battistin L, Cagnin A, Tonin P, Dam M. Behavioral and neurophysiological effects of repetitive transcranial magnetic stimulation on the minimally conscious state: a case study. Neurorehabil Neural Repair. 2011 Jan;25(1):98-102. doi: 10.1177/1545968310369802. Epub 2010 Jul 20.
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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.
Francesco Piccione, MD study director
San Camillo Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) and Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Vegetative State and Minimally Conscious State, run by IRCCS San Camillo, Venezia, Italy 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 5 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 25 Mar 2015. 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 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?
EEG coherence analysis (time frame: Change from baseline EEG coherence at the end of brain stimulation (two weeks)). 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 NCT01820923, which also lists 2 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 25 Mar 2015.