Trial document




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  DRKS00017761

Trial Description

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Title

Evaluation of conscious Signal interpretation TheRapy Improvement for DEep brain stimulation (DBS)

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Trial Acronym

STRIDE

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URL of the Trial

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Brief Summary in Lay Language

The present study is concerned with the improvement of the therapy of movement disorders and disorders of touch and pain (so-called sensory deficits) through the therapeutic use of deep brain stimulation (DBS).

The study will be conducted to examine the effects of consciously perceptible stimulation signals. We expect to create complementary treatments to improve the gait pattern in Parkinson's disease and to develop sensory neuroprostheses, ie prostheses used to correct for perceptual disorders, that can improve gait or other movments by providing sensory feedback of limb position to the brain.

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Brief Summary in Scientific Language

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) has become one
Standard therapy for the refractory stage of Parkinson's disease (PD). Patients
which are affected by PD, however, suffer from various residual symptoms, which can neither be controlled neuromodulatorily nor pharmacologically.
These are, for example, symptoms such as the phasic freezing of gait (FOG) phenomenon which impairs mobility and quality of life even under adequate DBS and medication.
In modern DBS systems (e.g., with octopolar electrodes), only a fraction of the available electrode contacts is used for therapeutically effective neuromodulation, while the remaining contacts remain completely unused.
In the present experiment different paradigms are to be evaluated, which test
whether these unused contacts can be used to extend the range of possible therapies of
DBS by the conscious processing of signals and thus to combat targeted symptoms.
With regard to the FOG, for example, it is known that through context-sensitive triggered rhythmic (e.g., auditory) and other signals (visual warning signs or cues) a FOGepisode can successfully dissolve. But so far an external signal generator was required (Bächlin et al., 2010, Ghai et al., 2018, Rochester et al., 2005). Rhythmic external signals (such as electrical stimulation of the skin) have also been used successfully in the past in order to improve walking speed, stride length and regularity of gait pattern in PD patients (Rosenthal et al., 2018). Instead of using external signal generators (such as loudspeakers, headphones, glued skin stimulators, biofeedback, spoken cues), the aim of this experiment is to evaluate whether the existing, already implanted hardware can be used directly to direct such signals via sensory fiber tracts such as the medial lemniscus to give symptom control to the patients.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017761
  •   2019/09/04
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  •   yes
  •   Approved
  •   235/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson disease
  •   G25.0 -  Essential tremor
  •   G50.1 -  Atypical facial pain
  •   G52.2 -  Disorders of vagus nerve
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Interventions/Observational Groups

  •   As the study-specific intervention, up to four sessions are performed on days 0-4 during hospitalisation. Duration approx. 30-90 minutes each.

    Day 0 or 1: After the patient has recovered sufficiently, the first session is held with the aim of calibrating the system.

    Day 1 or 2: Experimental Session 1: "Movement"

    Day 2 or 3: Experimental Session 2: "Communication"

    Day 3 or 4: Experimental Session 3: "Proprioception"

    After setting up the system, active participation of the patient is required for 30-90 minutes per session.

    The stimulation sequence is safe and is performed under the supervision of a study physician. The patient can interpret the signals by pressing a button on a box, these behavioural reactions then being measured and recorded. The stimulation sequence and measurements do not involve pain and can be stopped by the patient at any time.

    During one of the sessions, a gait examination is also performed to check, for example, whether the perception of the applied rhythmic stimulation signals can break through a FOG episode.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

To demonstrate in an explorative proof-of-concept approach that it is possible to feed information-bearing signals along the medial lemniscus fiber system for conscious interpretation by the patient, operationalized as the patient's performance in correctly recognizing and allocating the perceived signals (in %).

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Secondary Outcome

- To examine and describe the stimulation parameters and the interactions of these parameters with stimulation success of these fiber systems depending on the angle between electrode and fiber.

- To carry out a qualitative characterization of the types of information that the patient can use.

- To study the learning speed, robustness and reliability of the conscious signal interpretation by the patient(s).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/09/06
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Male or female patients of at least 35 years of age and max. 65 years;
2. Patients with one of the following diagnoses: a) essential tremor; b) tremor-dominant Parkinson's disease with thalamic target; c) drug therapy-refractory Parkinson's disease with effect fluctuations, DBS target in the subthalamic nucleus (STN); d) neuropathic pain;
3. Patients for whom according to DGN guidelines (www.dgn.org) the indication for conventional DBS surgery exists and in whom the stimulation electrodes regularly run through the pathways of the medial lemniscus or in its immediate vicinity;
4. Written, informed consent

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Exclusion Criteria

1. Patients with symptoms of dementia;
2. patients with signs of cerebral atrophy;
3. patients with immunodeficiency or under immunosuppressants;
4. pregnant or lactating women

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Addresses

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    • Universitätsklinikum FreiburgAbteilung für Stereotaktische und Funktionelle Neurochirurgie
    • Mr.  Dr.  Bastian   Sajonz 
    • Breisacher Straße 64
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgAbteilung für Stereotaktische und Funktionelle Neurochirurgie
    • Mr.  Dr.  Bastian  Sajonz 
    • Breisacher Straße 64
    • 79106  Freiburg im Breisgau
    • Germany
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    • Universitätsklinikum FreiburgAbteilung für Stereotaktische und Funktionelle Neurochirurgie
    • Mr.  Dr.  Bastian  Sajonz 
    • Breisacher Straße 64
    • 79106  Freiburg im Breisgau
    • Germany
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Sources of Monetary or Material Support

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    • CereGate GmbH
    • Mr.  Dr.  Bálint  Várkuti 
    • Große Reichenstraße 27
    • 20457  Hamburg
    • Germany
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    • Universitätsklinikum FreiburgAbt. für Stereotaktische und Funktionelle Neurochirurgie
    • Breisacher Straße 64
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.