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    Summary
    EudraCT Number:2017-000755-97
    Sponsor's Protocol Code Number:EPFL-CNBI-2017-01
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-03-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2017-000755-97
    A.3Full title of the trial
    Brain-computer interface and neuromuscular stimulation for rehabilitation following chronic stroke
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brain-computer interface and neuromuscular stimulation for rehabilitation following chronic stroke
    A.3.2Name or abbreviated title of the trial where available
    BCI-NMES-CVA
    A.4.1Sponsor's protocol code numberEPFL-CNBI-2017-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDefitech Chair in Brain-Machine Interface, EPFL
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDefitech Chair in Brain-Machine Interface, EPFL
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDefitech Chair in Brain-Machine Interface, EPFL
    B.5.2Functional name of contact pointCNBI, EPFL
    B.5.3 Address:
    B.5.3.1Street AddressChemin des Mines 9
    B.5.3.2Town/ cityGeneva
    B.5.3.3Post code1202
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041216935311
    B.5.5Fax number0041216935307
    B.5.6E-mailjose.millan@epfl.ch
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBCI+NMES therapy
    D.3.2Product code BCINMES
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Yes
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    I61 - Intracerebral haemorrhage
    I63 - Cerebral infarction
    Chronic condition (at least 10 months after occurrence of cerebrovascular accident)
    E.1.1.1Medical condition in easily understood language
    Stroke patients in their chronic phase.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Improvement of mobility, to enable performance of daily tasks. To be evaluated and quantified using the Fugl-Meyer Assessment: motor arm. The test will be carried out before the therapy, at the end of the therapy, and 6 months after the therapy.
    E.2.2Secondary objectives of the trial
    The following tests are carried out pre- and post-intervention:
    - Medical Research Council Power Test
    - National Institute of Health Stroke Scale (motor: Arm)
    - European Stroke Scale
    - Modified Ashworth Scale (spasticity)
    - Neuropsychological profile (with Montreal Cognitive Assessment and other tests)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age more than 18 years-old
    2) Victim of cerebrovascular accident (stroke)
    3) Patients in their chronic phase, more than 10 months after stroke.
    4) Severe paralysis of the arm
    5) Ability to understand information and ability to give a free and informed consent
    6) Good eyesight and hearing, or corrected
    7) First stroke (infarction), preferably ischemic stroke
    8) Unilateral cortical lesion (left or right hemisphere) or subcortical lesion, lesions of the supra-pontic corticospinal pathway causing a motor deficit of upper limb
    9) Paresis / central paralysis of the upper limb (the intervention focuses on upper limb; The presence of other motor deficits is not a criterion of exclusion)
    10) Ability to understand instructions to perform mental tasks, like mental imagery or attempt of motor activity (more specifically, the ability to imagine/attempt movements of the upper limbs). These capacities are estimated with neurophysiological assessments
    E.4Principal exclusion criteria
    1) Anything that hampers the proper EEG acquisition (for example, a skin contamination, scalp wound, dermatitis, uncontrolled/coarse muscle activity or an electrically noisy environment)
    2) Heavy medication affecting the central nervous system (including vigilance)
    3) Concomitant serious illnesses (comorbidity: fever, infection, metabolic, cardiac arrest)
    4) Multiple infarctions
    5) Complete unlilateral spatial neglect
    6) Inability to perform mental and motor imagery tasks
    7) Severe inability to understand and communicate (eg, severe aphasia), inability to understand the information given, the objectives of the study or instructions to perform tasks.
    8) Inability to concentrate for 2 hours.
    9) Severe dystonia / involuntary movements
    10) Other concurrent neurological disorders (eg, Parkinson's disease)
    11) High level of spasticity and / or pain
    12) Pacemakers, other active implants such as pumps, pacemakers for pain or phrenic pacing
    13) Severe or recent heart disease
    14) Implants in the area of the flow of current under the FES electrodes
    E.5 End points
    E.5.1Primary end point(s)
    1) Pre-intevention
    2) Post-intevention (3 to 5 weeks after begin of therapy)
    3) Follow up (after 6 months)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Pre-intevention
    2) Post-intevention (3 to 5 weeks after begin of therapy)
    3) Follow up (after 6 months)
    E.5.2Secondary end point(s)
    There are no secondary end-points
    E.5.2.1Timepoint(s) of evaluation of this end point
    There are no secondary end-points
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    NMES of control group driven by "sham" BCI
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Switzerland
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    April 2016
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 32
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Clinique Romande de Readaptation SUVA
    G.4.3.4Network Country Switzerland
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Hopitaux Universitaires de Geneva (HUG) - Beausejour
    G.4.3.4Network Country Switzerland
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Switzerland
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