Trial document





This trial has been registered retrospectively.
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  DRKS00010290

Trial Description

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Title

Comparison of error-related potentials between individuals with spinal cord injury and able-bodied subjects

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

We aim to examine a brain potential in the EEG that is evoked after conducting an erroneous action and compare it between able-bodied subjects and those with spinal cord injury. Both groups will have to conduct a suitable task that shall produce this "error-related potential" in the EEG. We expect to receive valuable information about whether or not subjects with spinal cord injury may successfully operate neuroprotheses which utilize this brain potential.

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Brief Summary in Scientific Language

To improve the reliability of non-invasive brain computer Interfaces (BCIs), it is considered to utilize the "error potential"(ErrP). This is an event-related potential that appears as a characteristic pattern in a subject´s EEG after he or she has conducted an erroneous action and gets conscious about it.
If a BCI-controlled neuroprosthesis was to perform a false movement, the user´s recognition of this mistake and the associated error-related potential could be used to cancel or revert the undesired action of the neuroprosthesis. However, most of the studies about the error-related potential were conducted in able-bodied subjects, therefore it has yet to be investigated wether an equivalent potential can be detected in spinal cord injured (SCI) individuals. Former studies showed a reduction of amplitude for the P300 potential in subjects with SCI, but it is unclear wether this is true also for the ErrP and if an online-recognition is possible.
This controlled, explorative study shall compare the ErrP between subjects with SCI and sex- and age-matched able-bodied individuals.
All participants will conduct a task in which they receive a visual instruction to move a shoulder joystick in one of two different directions. Afterwards they receive visual feedback about how they have performed. This is repeated 80 times per run and 6 runs will be accomplished. Errors occur both because of mistakes made by the participant and because of preprogrammed differences between the feedback shown and the actual shoulder movement. A high resolution (64-electrode) system will be used to measure EEG. In case of a feedback indicating an error, we expect an ErrP in the EEG.

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Organizational Data

  •   DRKS00010290
  •   2016/05/19
  •   [---]*
  •   yes
  •   Approved
  •   S-267/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G82 -  Paraplegia and tetraplegia
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Interventions/Observational Groups

  •   All able-bodied participants will conduct a task in which they receive a visual instruction to move a shoulder joystick in one of two different directions. Afterwards they receive visual feedback about how they have performed. This is repeated 80 times per run and 6 runs will be accomplished. Errors occur both because of mistakes made by the participant and because of preprogrammed differences between the feedback shown and the actual shoulder movement. A high resolution (64-electrode) system will be used to measure EEG. In case of a feedback indicating an error, we expect an ErrP in the EEG.
  •   Subjects with SCI perform the same experiment as able-bodied subjects
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Differences in number, amplitude, latency and general morphology of the error potentials measured in the EEG between spinal cord injured and able-bodied subjects

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Secondary Outcome

None

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/08/26
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

spinal cord injury, AIS A-D, preserved shoulder function

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Exclusion Criteria

Epilepsy

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Klinik für Paraplegiologie
    • Mr.  Dr.-Ing.  Rüdiger  Rupp 
    • Schlierbacher Landstr. 200a
    • 69118  Heidelberg
    • Germany
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    • Klinik für Paraplegiologie
    • Mr.  Dr.-Ing.  Rüdiger  Rupp 
    • Schlierbacher Landstr. 200a
    • 69118  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum HeidelbergKlinik für Paraplegiologie
    • Mr.  Dr.-Ing.  Rüdiger  Rupp 
    • Schlierbacher Landstr. 200a
    • 69118  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/09/01
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Trial Publications, Results and other Documents

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