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Vegetative StatePhase 2tDCS in DOCNCT01673126

Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

A Phase 2 study testing Anodal tDCS in people with Vegetative State and Minimally Conscious State, run by University of Liege at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and attention. Read more about this study

Who is it for?
Ages 15 to 75 years
What is being tested?
Anodal tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 siteBelgium
Study dates
Jan 2010to Dec 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 15 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • post-comatose patients
  • patients in vegetative/unresponsive or minimally conscious state
  • patients with stable cardiorespiratory parameters
  • patients free of sedative drugs and Na+ or Ca++ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)

Who cannot join

  • premorbit neurology antecedent
  • patients in coma or <1week after the acute brain insult
  • patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital of Liège

    Liège, Liège, 4000

Other trials in Belgium

About this study

Official title: Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Sham-controlled Randomised Double Blind Study

Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a double-blind sham-controlled experimental design.

Read the detailed description

Following severe brain damage and coma, some patients may remain in a vegetative state (VS) or minimally conscious state (MCS). At present, there are no evidence-based guidelines regarding the treatment of patients with disorders of consciousness (DOC).

Investigator aim to assess the effect of single session anodal (i.e., excitatory) transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPF) on the level of consciousness in DOC patients in a double blind randomized sham controlled study.

tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability at stimulation sites via weak polarizing currents, previously reported to transiently improve working memory and attention by stimulating the left DLPF in healthy subjects and patients with stroke, Parkinson's or Alzheimer's disease.

Being tested
Anodal tDCS, sham tDCS
Keywords
vegetative state, minimally conscious state, disorders of consciousness, transcranial direct current stimulation
Medical subject headings
Persistent Vegetative State, Consciousness Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anodal tDCSDevice

    patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)

  • sham tDCSDevice

    Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.

Study groups in NCT01673126
Study groupRoleWhat they receive
Anodal tDCSActive comparatorPatients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)
Receives: Device: Anodal tDCS
sham tDCSSham comparatorPatient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.
Receives: Device: sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in CRS-R Total Scores

    At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations

    The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.

    Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).

    The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors.

    Measured: Baseline and directly after the tDCS (20 minutes)

Secondary outcomes (3)

  1. Influence of Diagnosis on the Results

    Measured: participants will be followed for the duration of 1 year

  2. Influence of Etiology on the Results

    Measured: participants will be followed for the duration of 1 year

  3. Influence of Time Since Insult on the Results

    Measured: participants will be followed for the duration of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2012 (estimated)
  2. Study startJan 2010
  3. Primary completionAug 2010
  4. Study completionDec 2011

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01673126
Sponsor's protocol ID
2009/201
Acronym
tDCS in DOC
Status last verified
May 2014
First submitted
14 Aug 2012
Last updated
9 Jun 2014
Data monitoring committee
No

Publications

  • Multi-Society Task Force on PVS. Medical aspects of the persistent vegetative state (1). N Engl J Med. 1994 May 26;330(21):1499-508. doi: 10.1056/NEJM199405263302107.

    PubMed 7818633

  • Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.

    PubMed 11839831

  • Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, Henning S, Tergau F, Paulus W. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003 Nov 15;553(Pt 1):293-301. doi: 10.1113/jphysiol.2003.049916. Epub 2003 Aug 29.

    PubMed 12949224

  • Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.

    PubMed 14580622

  • Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.

    PubMed 15999258

  • Kang EK, Kim DY, Paik NJ. Transcranial direct current stimulation of the left prefrontal cortex improves attention in patients with traumatic brain injury: a pilot study. J Rehabil Med. 2012 Apr;44(4):346-50. doi: 10.2340/16501977-0947.

    PubMed 22434324

  • Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, Pascual-Leone A, Fregni F. Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease. J Neurol Sci. 2006 Nov 1;249(1):31-8. doi: 10.1016/j.jns.2006.05.062. Epub 2006 Jul 14.

    PubMed 16843494

  • Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.

    PubMed 18525028

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anodal tDCS in people with Vegetative State and Minimally Conscious State, 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 4 inclusion and 3 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 9 Jun 2014. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 CRS-R Total Scores (time frame: Baseline and directly after the tDCS (20 minutes)). 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 NCT01673126, which also lists 8 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 9 Jun 2014.

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