Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders

NCT02288533 | Completed DMC

• 1 other identifier: Regionale WP2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic consciousness disorders have high level of impact on public health and its costs.

Conditions

Minimally Conscious State; TBI

Keywords

Minimally Conscious State; tDCS

Outcome Measures

Primary Outcomes (1)

• Coma Recovery Scale Revised (CRS-R)

  behavioural scale (visual, auditory, motor, verbal, communication, arousal)

  Change measures (weeks: -2,0,1,2,4)

Secondary Outcomes (4)

• single-pulse transcranial magnetic stimulation (TMS)

  Change measures (weeks: -2,0,1,2,4)

• functional near infrared spectroscopy (fNIRS)

  Change measures (weeks: -2,0,1,2,4)

• electroencephalography (EEG)

  Change measures (weeks: -2,0,1,2,4)

• Circulating Biomarkers

  Change measures (weeks: -2,0,1,2,4)

Study Arms (1)

real-tDCS

EXPERIMENTAL

Participants will receive tDCS over the primary motor cortex bilaterally (M1). The excitability-enhancing anode electrode (saline-soaked sponge electrode - 16cm2) will be placed over the primary motor cortex, C3 and C4 (10/20 international EEG system). The excitability-diminishing cathode electrode will be placed over the supraorbital area. We will use the following stimulation parameters: intensity of 2 milliampere and for 40 minutes (10 consecutive sessions).

Device: real-tDCS

Interventions

real-tDCS DEVICE

Participants will receive tDCS over the primary motor cortex bilaterally (M1). The excitability-enhancing anode electrode (saline-soaked sponge electrode - 16cm2) will be placed over the primary motor cortex, C3 and C4 (10/20 international EEG system). The excitability-diminishing cathode electrode will be placed over the supraorbital area. We will use the following stimulation parameters: intensity of 2 milliampere and for 40 minutes (10 consecutive sessions).

real-tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males and females aged \>18 years old and \<70 years old
• diagnosis of disorders of consciousness classified as MCS according to criteria of American Academy of Neurology1.
• traumatic etiology (\>12 months after the acute injury)

You may not qualify if:

• contraindications to single pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants, history of seizures, metal in the head, implanted brain medical devices.
• contraindications to tDCS such as metal in the head, implanted brain medical devices.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Ferrara University Hospital

Ferrara, Italy, Italy

Location

MeSH Terms

Conditions

Persistent Vegetative State

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sofia Straudi, MD

  Ferrara Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: November 11, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)