Completed

Study on the Use of Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation to Promote Diagnosis, Prognosis and Innovative Rehabilitation in Patients in Vegetative and Minimally Conscious State.

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What is being tested

Transcranial direct current stimulation (tDCS)

+ Repetitive Transcranial Magnetic Stimulation (rTMS)

+ Transcranial Direct Current Stimulation (SHAM)

Device
Who is being recruted

Brain Damage, Chronic+8

+ Brain Diseases

+ Central Nervous System Diseases

From 18 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2011
See protocol details

Summary

Principal SponsorIRCCS San Camillo, Venezia, Italy
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2011

Actual date on which the first participant was enrolled.

The aim of this study is to determine whether transcranial brain stimulations, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients in vegetative and minimally conscious state.

NCT01820923
Principal SponsorIRCCS San Camillo, Venezia, Italy
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesConsciousness DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUnconsciousnessNeurobehavioral ManifestationsPersistent Vegetative State

Criteria

5 inclusion criteria required to participate
Age between 18 and 65 years
Diagnosis of vegetative state od minimally conscious state defined by the Disability Rating Scale with a score between 17 and 29
Stable clinical condition
Time from the lesion: more than 4 months
Show More Criteria
6 exclusion criteria prevent from participating
Extensive hemorrhage or ischemia
Metallic clips or intracranial implants
Pacemaker e Baclofen infusion
Presence of drugs influencing arousal or awareness
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Brain stimulation will consist of 4 types of intervention: real transcranial direct current stimulation (two weeks, five days a week) a week of wash-out Sham transcranial direct current stimulation (two weeks, five days a week) two weeks of wash-out real repetitive transcranial magnetic stimulation (two weeks, four days a week) a week of wash-out Sham repetitive transcranial magnetic stimulation (two weeks, three days a week) Stimulations will be counterbalanced between patients.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

IRCCS San Camillo Foundation

Venice, ItalyOpen IRCCS San Camillo Foundation in Google Maps
CompletedOne Study Center