Trial document




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  DRKS00007832

Trial Description

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Title

Brain-computer interface and neuromuscular stimulation for rehabilitation following acute stroke

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Trial Acronym

BCI-NMES-CVA

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URL of the Trial

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Brief Summary in Lay Language

Muscle stimulation is commonly performed as a part of routine rehabilitation therapy following stroke, in order to improve limb mobility. The time point at which a patient attempts to move their hand can be determined through sensors applied to the scalp. Timing muscle stimulation with a movement attempt has been shown to improve the general mobility of the arm in patients who had suffered a stroke over 10 months previously. In the time directly following a stroke, many brain processes are reorganized, suggesting that starting the therapy directly following the stroke could be more effective. In order to study the processes involved, EEG and magnet-based measurements will also be performed before and after the therapy, in order to explore what changes take place in brain processing. The time period during which patients may be included has been extended to 4 weeks, which remains within the acute period. Our experience has shown that patients who have suffered an acute stroke frequently require further investigations before they can be transferred to the Rehabilitation Centre, where the therapy can start. By extending the inclusion period, we can increase recruitment and at the same time investigate a patient group for whom application of the therapy is in practice possible.

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Brief Summary in Scientific Language

Following paresis resulting from haemorrhagic or ischaemic stroke, movement of the limbs on the affected side of the body must be re-learned. Healthy brain areas may take over motor neurone control, or neurons in the penumbra of the lesion may be triggered to take over the function of the damaged neurons, through stimulation and use of these areas. Brain-computer interface (BCI) controlled stimulation of the musculature of the affected limbs offers the possibility of coupling brain processes directly with limb movement in time. While EEG signals are recorded, patients will be asked to move their wrist. During this time, a BCI will be trained to recognise the brain signals produced by the patient and trigger an automatic movement of the affected hand through neuromuscular electrical stimulation (NMES). (That is, data collected from the patient when it was known whether or not the patient was attempting to move or to relax will be used to set the BCI.) The aim is that the patient newly learns to make the movement, through the coupling of the thought of moving with the feedback produced by an actual movement.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00007832
  •   2015/02/24
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  •   yes
  •   Approved
  •   177/14, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1167-4386 
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Health Condition or Problem studied

  •   I61 -  Intracerebral haemorrhage
  •   I63 -  Cerebral infarction
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Interventions/Observational Groups

  •   Test group (20 participants): the arm musculature will be stimulated at the timepoint at which the patient attempts to move, determined from the EEG.
  •   Control group (20 participants): the electrodes will also be placed, but the stimulation timing will be random.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Improvement of mobility, to enable performance of daily tasks. To be evaluated and quantified using the Fugl-Mayr Assessment: motor arm.

The test will be carried out before the therapy, at the end of each week of therapy, and 6 months after the therapie.

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Secondary Outcome

The following tests will be carried out before the therapy, after 3 and 5 weeks, and 6 months after the therapy:
- Medical Research Council Power Test
- Rivermead Test
- Barthel Index
- National Institute of Health Stroke Scale (motor: Arm)
- European Stroke Scale
- Modified Ashworth Scale (spasticity)
- Sensory deficits (Since feedback is visual as well as sensory, these patients will be included. Baseline 2-point discrimination and proprioceptive tests will be performed.)
- Standard clinical evaluation of the cranial and peripheral nerves, gait, Romberg test
- Neuropsychological profile (with Montreal Cognitive Assessment)
- Goal attainment questionnaire
- Stroke Impact Scale

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Countries of Recruitment

  •   Germany
  •   Switzerland
  •   Italy
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/02/23
  •   40
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- First stroke (thrombotic or haemorrhagic), diagnosed with CT or MRI, lasting more than 24 hours to 4 weeks
- Reduced or absent power of the affected extremity (arm/hand)

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Exclusion Criteria

- sever aphasia
- Medical Research Council Power Test: >= 3
- cognitive impairment leading to inability to perform the tasks: Montreal Cognitive Assessment (> 25)
- severe depression
- medically unstable (postural hypotension, sepsis, epilepsy, severe renal failure, hemispatial neglect, severe visual impairment, fixed joint contractures, skin condition which could be worsened by electrode placement)
- certain medications (L-dopa, amantadine. Antidepressive medication is permissible.)
- history of epilepsy
- Fatigue Severity Scale: > 36/63
- Pain Scale: > 5/10

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Addresses

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    • Universitätsklinik für Neurologie
    • Mr.  Prof. Dr.  Hans-Jochen  Heinze 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Ecole Polytechnique Federale de Lausanne
    • Mr.  Prof.  Jose  Millan 
    • Lausanne
    • Switzerland
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    • Median Klinik NRZ Magdeburg
    • Mr.  Prof. Dr. med.  Michael  Sailer 
    • Gustav-Ricker-Str. 4
    • 39120  Magdeburg
    • Germany
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    • Clinique romande de réadaptation
    • Mr.  Dr.  Phillippe  Vuadens 
    • Avenue du Grand-Champsec 90
    • 1950  Sion
    • Switzerland
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    •   +41 27 603 30 30
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    • Institution de Lavigny
    • Dr.  Manuel  Salazar 
    • Route du Vignoble 60
    • 1175  Lavigny
    • Switzerland
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    •   +41 21 821 45 45
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    • Centro Unico Prentazioni C.U.P.Ospedale San Camillo IRCCS
    • Mr.  Dr.  Francesco  Piccione 
    • Via Alberoni 70
    • 30126  Lido de Venecia VE
    • Italy
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    • Universitätsklinik für Neurologie
    • Ms.  Dr. (MBBS, PhD)  Catherine  Sweeney-Reed 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Unversitätsklinik für Neurologie
    • Ms.  Dr.  Catherine  Sweeney-Reed 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Neurologie
    • Mr.  Prof. Dr. med.   Hans-Jochen  Heinze 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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