Trial document




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  DRKS00003515

Trial Description

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Title

Influence of individual genetic determination of the BDNF Val66Met polymorphism on plasticity-related sensorimotor recovery after ischemic stroke

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

In the Western industrialized nations stroke is the most common cause of long-term disability in adults. The testing and development of new therapeutic approaches must be promoted to enable stroke patients to restart a self-determined and independent life. In this context, the rehabilitation of arm and hand functions is of high importance, since the hands are the most important tools for interacting with the environment.

Our study has two objectives. Firstly, a new electrical stimulation program for sensorimotor hand rehabilitation has to be tested on its effectiveness. Secondly, a genetic investigation is planned, to reveal reasons for the often varying success of rehabilitation programs in stroke patients. Our hypothesis is that there may be a certain genetic marker that explains for the different outcomes of rehabilitation measures.

Two groups of stroke patients suffering from unilateral impairment of arm-hand function will participate in our study.All participants will be tested for the above mentioned genetic marker, which only requires a quick blood withdrawal. In the first group, the impact of a standard rehabilitation program on the restoration of arm-hand function will be tested. In the second group, all patients receive electrical stimulation of the affected hand in addition to a daily standard rehabilitation program.
The success of both interventions will be investigated and by an assessment of individual arm-hand performance of the patients at the beginning and at the end of the treatment.

By comparing the results of both groups we aim at revealing whether the specific genetic marker influences the rehabilitation ability of humans and whether a targeted electrical stimulation of the hand can improve the therapeutic results of a standard measure.

In future the results of this study may help to estimate the individual amount of treatment required to restore sensorimotor functions in stroke patients. Furthermore, standard interventions might improved by additional application of electrical stimulation.

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Brief Summary in Scientific Language

In the Western industrialized nations stroke is the most common cause of long-term disability in adults. There is general agreement among that the recovery of sensorimotor performance is based on extensive neuroplastic reorganization processes. Although plastic processes in the brain occur spontaneously to a limited extent, specific therapeutic interventions are used to
evoke reorganization and associated behavioral improvements.

The planned study is designed to reveal possible interactions between the individual determination of the BDNF Val66Met polymorphism and sensorimotor improvement following rehabilitation measures. The growth factor BDNF is relevant to basic brain functions such as plasticity and repair. In detail, the impact of the individual BDNF determination on sensorimotor rehabilitation is tested. Therefor the effects of a standard rehabilitation program and a standard rehabilitation program with additional peripheral electrical stimulation will be compared concerning the recovery of sensorimotor and neurophysiological parameters.

We assume that the determination of the BDNF Val66Met polymorphism determines the extent of neuroplastic
reorganization in the brain and thereby the success of therapeutic interventions.

In future, the findings of the described project might be
used to adjust individual therapy programs to the need and the rehabilitation potential of stroke patients.

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Organizational Data

  •   DRKS00003515
  •   2012/01/31
  •   [---]*
  •   yes
  •   Approved
  •   3729-10, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  •   U1111-1127-4599 
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Health Condition or Problem studied

  •   I63 -  Cerebral infarction
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Interventions/Observational Groups

  •   Target group:
    Patients with ischemic infarction and a subsequent unilateral sensorimotor impairment of upper limb performance attending standard therapy (OT/PT) and additional application of peripheral electrical stimulation (45 min per day for 10 days)
  •   Control group:
    Patients with ischemic infarction and a subsequent unilateral sensorimotor impairment of upper limb performance attending standard therapy (OT/PT for 10 days)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Assessment of sensorimotor performance before and after 10 days of standard rehabilitation (control group).
Assessment of sensorimotor performance before and after 10 days of standard rehabilitation and additional daily electrical hand stimulation (control group)

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Secondary Outcome

Evaluation of the suitability for daily use of the electrical stimulation method (application, comfort). Evaluation of the subjective experience of the patient (performance improvements).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/02/01
  •   80
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   70   Years
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Additional Inclusion Criteria

Aged between 40 and 70 years;

Right-handedness before the infarction according to the Einburgh Inventory of Handedness;

Ischemic infarct (cortical/subcortical) in the coverage area of the middle cerebral artery, according to cranial CT or MRI;

Unilateral impairment of sensorimotor performance of upper extremities, i.e. an easy-to-moderate hemiparesis: Grade 3-5 according to MRC;

Ability to conduct subtest 1 and 2 of the Jebsen-Taylor Hand Function Test

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Exclusion Criteria

Lack of knowledge of German language (subjective assessment of the experimenter);
Cognitive impairment in accordance DemTect (score <10; without the task 2 "convert numbers");
Taking CNS-active drugs of any kind;
Residual symptoms of previous neurological diseases (including stroke, lesions, polyneuropathy);
Psychiatric disorders that might influence therapy;
Pacemaker (safety criterion for the electrical stimulation);
Increased muscle tone in the proximal or distal arm muscles (> 1 + according to MAS);
Excessive hand tremor (≤ 1 in subitem 20; 21 of the UPDRS);
Absolute loss of sensorimotor performance of upper extremities (hemi- or paraplegia) and severe paresis (MRC grade 0-2; inability to perform subtest 1 and 2 of the Jebsen-Taylor Hand Function Test);
Aphasia, preventing an informed consent;
Neglect;
Apraxia;
Perception threshold of electric stimulation of 20 mA / channel

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Addresses

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    • Neurologischen Klinik und Poliklinik BG-Universitätsklinikum Bergmannsheil Ruhr-Universität Bochum
    • Mr.  Prof. Dr.  Martin  Tegenthoff 
    • Bürkle-de-la-Camp Platz 1
    • 44789  Bochum
    • Germany
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    • Neural Plasticity Lab Institut für Neuroinformatik Ruhr-Universität Bochum
    • Mr.  PD Dr.  Hubert  Dinse 
    • Universitätsstrasse 150, NB 3 Nord 68
    • 44780  Bochum
    • Germany
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    • Neural Plasticity Lab Institut für Neuroinformatik Ruhr-Universität Bochum
    • Mr.  Dr.  Tobias  Kalisch 
    • Universitätsstrasse 150, NB 3 Nord 67
    • 44780  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Neurologischen Klinik und Poliklinik BG-Universitätsklinikum Bergmannsheil Ruhr-Universität Bochum
    • Mr.  Prof. Dr.  Martin  Tegenthoff 
    • Bürkle-de-la-Camp Platz 1
    • 44789  Bochum
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/01
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* This entry means the parameter is not applicable or has not been set.