Trial document




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  DRKS00012748

Trial Description

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Title

Body representation and sensorimotor function as agents for brain reorganization and behavior change: from chronic pain to immobility and dementia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Many disorders such as chronic pain, negative consequences after immobilization, and dementia are accompanied by altered body perception and reduced sensory and motor functions which are associated with dysfunctional plastic changes in the brain. Based on the development of novel psychological interventions targeting body representation, we devise new virtual and augmented reality-based training procedures to reestablish normal body representation and improve sensory, motor and cognitive function. We apply these interventions in post-injury pain and motor dysfunction, where the counteracting of long-term immobility by feedback of movement should shorten recovery times and preserve muscle function. Another novel application is in chronic musculoskeletal pain, where the systematic shaping of intact body representation including interoception, should reduce pain and pain behaviors and alter maladaptive brain circuits. We expand this approach to early dementia, where the breakdown of sensorimotor processing and immobility may be important in disease progression. The results might pave the way to new and innovative treatment approaches.

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Brief Summary in Scientific Language

Brain circuits involved in pain processing and body representation are closely connected and interact more than previously thought. Somatosensory, visual, interoceptive and motor processes contribute to the formation of body perception and can be combined in treatments designed to reestablish normal body representation. Based on the development of novel psychological interventions targeting body representation in phantom limb pain, we devise new virtual and augmented reality-based training procedures to reestablish normal body representation and improve sensory, motor and cognitive function. We apply these interventions in post-injury pain and motor dysfunction, where the counteracting of long-term immobility by feedback of movement should shorten recovery times and preserve muscle function. Another novel application is in chronic musculoskeletal pain, where the systematic shaping of intact body representation including interoception, should reduce pain and pain behaviors and alter maladaptive brain circuits. We expand this approach to early dementia, where the breakdown of sensorimotor processing and immobility may be important in disease progression. We employ novel implicit and explicit assessment methods of these perceptual and neuronal changes involving psycho-physics, computational modeling, physiological recordings and brain imaging methods. These studies are the basis for mechanistic treatment approaches and also advance basic research on body representation and multisensory integration.

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Organizational Data

  •   DRKS00012748
  •   2017/07/13
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  •   yes
  •   Approved
  •   2015-543N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F06.7 -  Mild cognitive disorder
  •   chronic musculoskeletal pain; post-injury pain and motor dysfunction
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Interventions/Observational Groups

  •   Experimental condition
    1. 80 students: Virtual mirror training after artificial immobilization of one arm (two weeks of daily training)
    2. 60 subjects with chronic musculoskelettal pain, 60 subjects with mild cognitive impairments: daily sensorimotor home training for 12 weeks
    3. 60 subjects with injury-induced immobilization: sensorimotor training for the duration of immobilization (daily training)
  •   Control condition
    1. Student group: Virtual mirror training of non-immobilized arm
    2. Subjects with chronic musculoskelettal pain, subjects with mild cognitive impairments: TAU, respectively cognitive training
    3. subjects with injury-induced immobilization: TAU
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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
  •   II
  •   N/A
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Primary Outcome

1. Student group: before training - after training (after 2 weeks), resp. experimental condition - control condition; sensorimotor changes (strength measurement)
2. Subjects with chronic musculoskelettal pain: before training - after training (after 12 weeks), resp. experimental condition - control condition; changes in pain level (multidimensional pain inventory)
3. Subjects with mild cognitive impairment: before training - after training (after 12 weeks), resp. experimental condition - control condition; changes in cognitive performance (Montreal Cognitive Assessment, CANTAB)
4. Subjects with injury-induced immobilization: experimental condition - control condition; degree of sensorimotor deficits (strength measurement, sensory thresholds; only after immobilization)

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Secondary Outcome


1. Student group: before training - after training, resp. experimental condition - control condition; cortical organisation of sensorimotor brain areas (fMRI)
2. Subjects with chronic musculoskelettal pain: before training - after training, resp. experimental condition - control condition; quality of life (SF-36)
3. Subjects with mild cognitive impairment: before training - after training, resp. experimental condition - control condition; biomarkers, e.g., Tau proteins
4. Subjects with injury-induced immobilization: experimental condition - control condition; reconvalescence time

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/08/01
  •   260
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Presence of group membership (chronic musculoskelettal pain; mild cognitive impairment; injury-induced immobilization; absence of these factors = healthy controls)

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Exclusion Criteria

MRI exclusion criteria, subjects unable to consent, pregnancy, current mental disorder

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Addresses

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    • Institut für Neuropsychologie und Klinische Psychologie, Zentralinstitut für Seelische Gesundheit
    • Ms.  Prof. Dr. Dr. h. c.  Herta  Flor 
    • J5
    • 68159  Mannheim
    • Germany
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    • Institut für Neuropsychologie und Klinische Psychologie, Zentralinstitut für Seelische Gesundheit
    • Ms.  Prof. Dr. Dr. h. c.  Herta  Flor 
    • J5
    • 68159  Mannheim
    • Germany
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    • Institut für Neuropsychologie und Klinische Psychologie Zentralinstitut für Seelische Gesundheit
    • Mr.  Dr.  Robin  Bekrater-Bodmann 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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