Trial document




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  DRKS00011844

Trial Description

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Title

tDCS for phobic postural vertigo

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Trial Acronym

tDCS-PPV

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URL of the Trial

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Brief Summary in Lay Language

phobic postural vertigo is a disorder between neurology and psychosomatics with vertigo, dizziness and concomitant depression. In this study, we will use transcranial direct current stimulation, a non-invasive brain Stimulation method, to reduce symptoms of phobic postural vertigo. Two sponge electrodes will be placed on the skull to stimulate frontal brain areas with a low direct current over several minutes. Several questionnaires and technical measures will be implemented to assess vertigo.

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Brief Summary in Scientific Language

Prospective randomized Placebo-controlled tDCS study in cross-over design. Consisting in 1 baseline block with psychoeducative elements, 1 active block (anode: F3, cathode: AF8) and 1 Placebo block (same electrode montage), 3-4 weeks of wsh-out period between blocks with follow-up after each block (FU1-3). Duration per Patient/controls: 3x5 weeks = 15 weeks (Measures and Stimulation always in the evening). It is hypothesized that anodal, but not sham stimulation or the first block with psycho-education will reduce dizziness symptoms. However the first block is needed to exclude unspecific interventional effects due to enrolment in the study. It is assumed that the prefrontal Cortex is strengthened in its control function over anxiety and vertigo after active Stimulation.

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Organizational Data

  •   DRKS00011844
  •   2017/03/07
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  •   yes
  •   Approved
  •   530-16, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   F45.8 -  Other somatoform disorders
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Interventions/Observational Groups

  •   Block 1 (3-4 Wochen): Wash-out Phase after enrolment. Only psycho-education as Intervention. Then follow-up.
    Block 2: active tDCS, anode F3, cathode AF8, 5 Treatments, 30 min each, 2 mA current strength OR Placebo tDCS (same set-up), double-blind in cross-over design. Then 3-4 weeks wash-out and follow-up.
    Block 3: same as block 2, other condition. Then wash-out Phase 3-4 weeks and follow-up.
  •   Placebo tDCS (no current flow), anode F3, cathode AF8, 5 Placebo Treatments for 30 min each
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

active Stimulation is superior to sham Stimulation in Terms of reduction of diziness and anxiety (questionnaires: DHI, BDI, HADS, WHOQoL) at the time Point of follow-up (3-4 weeks after Stimulation).

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Secondary Outcome

active Stimulation is superior to sham Stimulation in Terms of reduction of posturography measures, VOG, SLO at the time Point of follow-up (3-4 weeks after Stimulation).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/03/07
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients (male/female) in Age 18-50. Secondary somatoform vertigo since <2 years with gait disturbance without objectively measurable or visible disturbance of gait and posture. Vertigo is described as dizziness with undulating incapability of gait and posture, fear attacks without dropping, partially described also as Body sway. Dizziness is modulated by the Situation. Vestibular diagnostics without pathology (calorics, head Impulse test, oculomotorics, subjetive visual vertical, Scanning Laser Ophtalmoskop , Video oculography), no pathology in posturography except for typical PPV pattern. No medication (e.g. selective Serotonin reuptake inhibitor).

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Exclusion Criteria

Alcohol or drug abuse, pregnancy, other psychiatric disorder, post stroke, malignant diseases, electronic or metal implants.

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Addresses

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Sources of Monetary or Material Support

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    • Neurologische Klinik der Universität München
    • Ms.  Dr.  Valerie  Kirsch 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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