Fronto-parietal tDCS in Severely Brain Injured Patients With Disorders of Consciousness

Minimally Conscious State Clinical Trial

Official title:

Effect of Fronto-parietal Transcranial Direct Stimulation on the Level of Consciousness in Patients With Disorders of Consciousness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626403
• Other study ID #: 2014/280
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: September 2017

Study information

• Verified date: January 2019
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous studies showed that anodal transcranial direct current stimulation (tDCS) transiently improves performance of memory and attention. In severely brain injured patients with disorders of consciousness (DOC), a single stimulation over the left dorsolateral prefrontal cortex has shown to improve patients' sign of consciousness. Nevertheless, other brain areas could be stimulated in order to increase the number of responders. In this study, investigators will assess the effects of bilateral fronto-parietal tDCS on Coma Recovery Scale-Revised (CRS-R) scores in patients with DOC in a double-blind sham-controlled experimental design.

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). A previous study showed that a single stimulation (using transcranial direct current stimulation - tDCS) of the left prefrontal cortex induces an behavioral improvement in some patients in DOC. Nevertheless, only 43% of patients in MCS responded to the stimulation. Therefore, it is needed to find new protocols to increase the number of responders and improve the effect of tDCS in patients with DOC.

In this study, investigators aim to assess the effect of single session anodal (i.e., excitatory) transcranial direct current stimulation (tDCS) over right and left fronto-temporal cortices (using 4 anodes and 4 cathodes), on the level of consciousness of patients with DOC, in a double blind randomized sham controlled study. The anodes will be placed over F3, F3, CP5 and CP6.

tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability under the electrodes, via weak polarizing currents. It has been reported that anodal tDCS transiently improves working memory and attention by stimulating the left DLPF in healthy subjects and patients with stroke, Parkinson's or Alzheimer's disease. By increasing the surface of the stimulated area, it is expected to increase the number of responders as patients' brain lesion are very heterogeneous and widespread.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• post comatose patients

• patients in minimally conscious state

• patients with stable condition

• patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

• premorbid neurology antecedent

• patients in coma

• patients < 28 days after the acute brain injury

• patients with a metallic cerebral implant

• cranioplasty

• shunt

Related Conditions & MeSH terms

• Consciousness Disorders
• Disease
• Disorders of Consciousness
• Minimally Conscious State
• Persistent Vegetative State
• Vegetative State

Intervention

Device:
• Anodal tDCS
Patients will receive anodal tDCS during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised) and an EEG. The anodes will be placed over F3, F4, CP5, and CP6 in order to stimulation the fronto-parietal cortex bilaterally.
• Sham tDCS
Identical to anodal tDCS, except that the stimulation will be stopped after 15 seconds.

Locations

Country	Name	City	State
Belgium	University of Liege	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the CRS-R total score	CRS-R will be performed before and after tDCS (anodal and sham). Comparison of the treatment effect (CRS-R total score after tDCS minus before) between real and sham tDCS	Baseline and directly after the tDCS (20 minutes)
Secondary	Change in EEG	8 channels EEG will be record before and after tDCS to record potential cortical changes induce by the stimulation.	Baseline and directly after the tDCS (20 minutes)
Secondary	Change in CRS-R subscores	Same analysis as for CRS-R total score but on each of the 6 sub-scales	Baseline and directly after the tDCS (20 minutes)