Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC

Spasticity, Muscle Clinical Trial

Official title:

Effects of Multichannel Transcranial Direct Current Stimulation to Reduce Hypertonia in Patients With Prolonged Disorders of Consciousness: a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797573
• Other study ID #: 2014/280B
• Status: Completed
• Phase: Phase 1
• Start date: January 20, 2014
• Est. completion date: December 13, 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 transcranial direct current stimulation (tDCS) transiently improves performance of motor function in stroke patients, as well as decrease muscle hypertonia. 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 manage other symptoms occurring in this population of patients, such as muscle hypertonia. In this study, investigators will assess the effects of bilateral fronto-central tDCS on spasticity as measured with the Modified Ashworth Scale (MAS) and on the 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, patients with DOC suffer from other invalidating dysfunctions such as spasticity (muscle hypertonia). In sroke patients, the inhibition of the motor cortex through cathodes placed over the motor region showed to reduce spasticity.

In this study, investigators aim to assess the effect of single session of transcranial direct current stimulation (tDCS) over right and left fronto-central areas (using 2 anodes and 2 cathodes), on the level of hypertonia and the level of consciousness of patients with DOC, in a double blind randomized sham controlled study. The anodes will be placed over F3 and F4, and the cathodes over C3 and C4.

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 motor functions in healthy subjects and patients with stroke or Parkinson's disease.

By reducing the activity of the motor cortex (cathodes) and increasing the activity of the prefrontal cortex (anodes) we expect to observe a better motor function in patients with DOC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 13, 2017
• Est. primary completion date: June 28, 2014
• 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
• Disorder of Consciousness
• Minimally Conscious State
• Muscle Hypertonia
• Muscle Spasticity
• Persistent Vegetative State
• Spasticity, Muscle
• Vegetative State

Intervention

Device:
• tDCS
tDCS will be applied during 20 minutes with a current of 1 mA preceded and followed by a behavioral assessments (Modified Ashworth Scale and Coma Recovery Scale Revised) and an EEG. The anodes will be placed over F3 and F4 and the cathodes over C3 and C4.
• sham tDCS
Indentical to the active tDCS, except that the stimulation is terminated after 5 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 MAS scores	Modified Ashworth Scale (MAS) will by assessed before and after tDCS (active and sham). Comparison of treatment effect (MAS score after tDCS minus before) between active and sham tDCS. The MAS is a 5 points scale going from 0 (no spasticity) and 5 (extreme spasticity).	baseline and directly after tDCS (20 minutes)
Secondary	Change in the CRS-R total score	Coma Recovery Scale Revised (CRS-R) will be performed before and after tDCS (anodal and sham). Comparison of the treatment effect (CRS-R total score score after tDCS minus before) between real and sham tDCS. The CRS-R is 23 points scale with 6 sub-scales (lower scores refer to reflexes, while higher scores refer to more complex behaviors). The total score is the sum of the scores in the 6 sub-scales.	Baseline and directly after the tDCS (20 minutes)]
Secondary	Change in brain oscillations	8 channels electroencephalography (EEG) will be record before and after tDCS to record potential cortical changes induce by the stimulation. EEG power will be compared in different bandwidths (delta, theta, alpha, beta).	Baseline and directly after the tDCS (20 minutes)