Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00006779

Trial Description

start of 1:1-Block title

Title

Evaluation of clinical, neurophysiological and imaging parameter to detect and characterize chronic central neuropathic pain after spinal cord injury

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Pain is a common complication after spinal cord injury (SCI). In terms of therapy, neuropathic pain, resulting from injuries of the central or peripheral nervous system, is particularly challenging. The underlying mechanisms leading to neuropathic pain after SCI still remain unclear. To date, no reliable tool exists which is capable of predicting patients at risk for developing such a pain syndrome. Once neuropathic pain has occurred, a complete relief from pain is only achievable in rarest cases. For the purpose of developing a specific therapy, a better understanding of underlying mechanisms is needed. It is already possible to detect the specific symptoms and to make the diagnosis of neuropathic pain. However, it is still not possible to clearly link these symptoms and their different characteristics to corresponding stuctural and/or functional changes within the nervous system. Using clinical and instrument-based examination methods, it could be possible to identify specific marker, which are capable of detecting neuropathic pain not only subjectively - which means "felt/described by the patient" - but also objectively - which means "indicated by structural/functional findings within the nervous system". Physical activity can influence neuropathic pain in a postive way. Thus, it should also be investigated how sensitive potential marker that are linked to neuropathic pain could be influenced by physical activity. Given that these intentions prove to be successful, it could finally be conceivable to evaluate these marker with respect to their predictive capabilities in neuropathic pain syndromes.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Options for treating neuropathic pain are yet very limited. These are primarily symptomatic and drug-based (anticonvulsives, antidepressants, opioids) therapies. A continuous use of medication provided, a maximum pain relief of about 30 to 50 % can be considered as reasonable. Peripheral and central neural circuitries, which are involved in pain processing, exhibit a high degree of structural plasticity in spinal cord injury. It is assumed that such a plasticity could also entail negative effects - so-called maladaptive plasticity - representing the structural correlate for chronic neuropathic pain. The respective changes are supposed to be located on spinal (below the injury site), subcortical and/or cortical level. Sensorimotor activation of the nervous system below the spinal cord injury site - in terms of electrical stimulation or exercise therapy (treadmill training, bicycle Ergometer) - is known to be capable of triggering structural and functional plasticity. It also represents an effective, non-pharmacological tool for reducing the severity of chronic neuropathic pain. In contrast to animal models, it is not possible to perform histological examination in humans, in order to prove the damage of neural structures and the existence of maladaptive plasticity on the level of spinal cord and brain. Specific standardized and appropriate clinical, neurophysiological and imaging assessments, which are related to neuropathic pain, could serve as surrogates for such a structural and functional plasticity in humans, though. This again would probably expand the currently established primarily questionnaire-based evaluation of neuropathic pain by structural and funcional aspects.

This study thus aims at the objective evaluation of three main questions:

(1) Is there a pattern of sensory dysfunction that specifically characterizes the group of SCI patients, suffering from neuropathic pain?
(2) Is there a specific pattern of findings that suggests possible spinal and/or supraspinal maladaptive plasticity in the Group of SCI?
(3) Is it possible to influence these parameters by delivering additional sensorimotor input, as it is known to be capable of modulating pain?

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006779
  •   2014/09/23
  •   [---]*
  •   yes
  •   Approved
  •   S-660/2013, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1162-0834 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G82.4 -  Spastic tetraplegia
  •   M79.2 -  Neuralgia and neuritis, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Evaluation of 12 healthy subjects (once) by means of pain questionnaires, psychometric tests, electrophysiological examinations (H-reflex, flexor-reflex, LEP, SSEP), quantitative sensory testing and imaging (VBM-MRI).
  •   Evaluation of 12 spinal cord injured subjects without neuropathic pain (twice; before and after sensorimotor activation) by means of pain questionnaires, psychometric tests, electrophysiological examinations (H-reflex, flexor-reflex, LEP, SSEP), quantitative sensory testing and imaging (VBM-MRI).

  •   Evaluation of 12 spinal cord injured subjects with neuropathic pain (twice; before and after sensorimotor activation) by means of pain questionnaires, psychometric tests, electrophysiological examinations (H-reflex, flexor-reflex, LEP, SSEP), quantitative sensory testing and imaging (VBM-MRI).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Detection of neuropathic pain in chronic spinal cord injured patients by means of pain questionnaires and subsequent evaluation of findings from (1) Quantitative Sensory Testing/clinical examination, (2) H-Reflex/flexor-reflex/LEP/SSEP and (3) magnetic resonance imaging (VBM) compared to findings from the same methods in chronic spinal cord injured patients without neuropathic pain and healthy subjects.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Influenceability of these parameters by sensorimotor activation.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/05/19
  •   36
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Able to consent; chronic spinal cord injury at least 12 months post injury; neurological Level of injury C5 to Th10

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Sensory impairment in dermatome C2 on both sides; artificial respiration; cauda-equina syndrome; epilepsy; impaired cognitive ablilities; pre-existing mental disorder; cardiac pacemaker; other active implants (e.g. phrenic pacemaker, drug pumps); metal implants less than 20 cm away from electrodes for electrical stimulation; severe traumatic brain injury in clinical history; pre-existing sensory deficits or dieseases which entail polyneuropathy (e.g. diabetes mellitus); severe primary internistic diseases (e.g. oncological, cardilogical); pregnancy.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Paraplegiologie,Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.  Norbert  Weidner 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.  Norbert  Weidner 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
    • Mr.  Dr.  Steffen  Franz 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.  Norbert  Weidner 
    • SChlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.