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Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC

Primary Purpose

Vegetative State, Minimally Conscious State, Spasticity, Muscle

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
tDCS
sham tDCS
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vegetative State focused on measuring transcranial direct current stimulation, disorder of consciousness, muscle hypertonia, spasticity, vegetative state, minimally conscious state

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Liege

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active tDCS

sham tDCS

Arm Description

Patients will receive tDCS (bilateral fronto-central stimulation) during 20 minutes preceded and followed by a clinical assessment (Modified Ashworth Scale and Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).

Patients will receive sham tDCS (5 seconds of stimulation) during 20 minutes preceded and followed by a clinical assessment (Modified Ashworth Scale and Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).

Full Information

First Posted
January 3, 2019
Last Updated
January 4, 2019
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT03797573
Brief Title
Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC
Official Title
Effects of Multichannel Transcranial Direct Current Stimulation to Reduce Hypertonia in Patients With Prolonged Disorders of Consciousness: a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 20, 2014 (Actual)
Primary Completion Date
June 28, 2014 (Actual)
Study Completion Date
December 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vegetative State, Minimally Conscious State, Spasticity, Muscle, Disorder of Consciousness
Keywords
transcranial direct current stimulation, disorder of consciousness, muscle hypertonia, spasticity, vegetative state, minimally conscious state

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Active Comparator
Arm Description
Patients will receive tDCS (bilateral fronto-central stimulation) during 20 minutes preceded and followed by a clinical assessment (Modified Ashworth Scale and Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
Patients will receive sham tDCS (5 seconds of stimulation) during 20 minutes preceded and followed by a clinical assessment (Modified Ashworth Scale and Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
Indentical to the active tDCS, except that the stimulation is terminated after 5 seconds.
Primary Outcome Measure Information:
Title
Change in MAS scores
Description
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).
Time Frame
baseline and directly after tDCS (20 minutes)
Secondary Outcome Measure Information:
Title
Change in the CRS-R total score
Description
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.
Time Frame
Baseline and directly after the tDCS (20 minutes)]
Title
Change in brain oscillations
Description
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).
Time Frame
Baseline and directly after the tDCS (20 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24574549
Citation
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.
Results Reference
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Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC

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