- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03797573
Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC
Effects of Multichannel Transcranial Direct Current Stimulation to Reduce Hypertonia in Patients With Prolonged Disorders of Consciousness: a Pilot Study.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Liege, Belgium, 4000
- University of Liège
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: active tDCS
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).
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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.
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Sham Comparator: sham tDCS
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).
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Indentical to the active tDCS, except that the stimulation is terminated after 5 seconds.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in MAS scores
Time Frame: baseline and directly after tDCS (20 minutes)
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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).
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baseline and directly after tDCS (20 minutes)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the CRS-R total score
Time Frame: Baseline and directly after the tDCS (20 minutes)]
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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.
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Baseline and directly after the tDCS (20 minutes)]
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Change in brain oscillations
Time Frame: Baseline and directly after the tDCS (20 minutes)
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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).
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Baseline and directly after the tDCS (20 minutes)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Brain Damage, Chronic
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Unconsciousness
- Consciousness Disorders
- Muscle Hypertonia
- Muscle Spasticity
- Persistent Vegetative State
Other Study ID Numbers
- 2014/280B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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