Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC

NCT03797573 | Completed Phase 1

• 1 other identifier: 2014/280B
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in the CRS-R total score

  Baseline and directly after the tDCS (20 minutes)]

• Change in brain oscillations

  Baseline and directly after the tDCS (20 minutes)

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

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).

Device: tDCS

sham tDCS

SHAM COMPARATOR

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).

Device: sham tDCS

Interventions

tDCS DEVICE

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.

active tDCS

sham tDCS DEVICE

Indentical to the active tDCS, except that the stimulation is terminated after 5 seconds.

sham tDCS

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• premorbid neurology antecedent
• patients in coma
• patients \< 28 days after the acute brain injury
• patients with a metallic cerebral implant
• cranioplasty
• shunt

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

University of Liege

Liège, 4000, Belgium

Location

Related 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.

  PMID: 24574549 BACKGROUND

MeSH Terms

Conditions

Persistent Vegetative State; Muscle Spasticity; Consciousness Disorders; Muscle Hypertonia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 9, 2019
• Study Start: January 20, 2014
• Primary Completion: June 28, 2014
• Study Completion: December 13, 2017
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)