Trial document




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  DRKS00007633

Trial Description

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Title

Multicenter, prospective, controlled randomized, single-blind study to evaluate the efficacy of vibrotactile neuro-feedback in addition to Ginkgo biloba special extract EGb 761® for the treatment of presbyvertigo

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of study is to investigate the efficacy, the safety and tolerability of 10- days of balance training with or without feedback by a device (VertiGuard® RT) counteracting falling tendency combined with Ginkgo biloba special extract EGb 761® in the treatment of presbyvertigo.

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Brief Summary in Scientific Language

The objectives of the multicenter, prospective, controlled, randomized, single-blind study are to evaluate the efficacy of vibrotactile neuro-feedback using VertiGuard® RT additionally to intake of EGb 761® in presbyvertigo. Furthermore, safety and tolerability of EGb 761® with and without vibrotactile neurofeedback using VertiGuard® RT will be assessed in patients with presbyvertigo.

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Organizational Data

  •   DRKS00007633
  •   2015/01/13
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  •   no
  •   Approved
  •   14/0350, Ethik-Kommission des Landes Berlin
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Secondary IDs

  •   2014-000303-28 
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Health Condition or Problem studied

  •   Presbyvertigo
  •   R42 -  Dizziness and giddiness
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Interventions/Observational Groups

  •   EGb 761®, dry extract from Ginkgo biloba leaves (DEV 35-67:1, extraction solvent: aceton 60 % (m/m)), 2x daily 80 mg oral intake for 12 weeks including 2 weeks (10 days of training, after 4 weeks only EGb 761® treatment) individually adapted balance training with vibrotactile neurofeedback
  •   EGb 761®, dry extract from Ginkgo biloba leaves (DEV 35-67:1, extraction solvent: aceton 60 % (m/m)), 2x daily 80 mg oral intake for 12 weeks including 2 weeks (10 days of training, after 4 weeks only EGb 761® treatment) individually adapted balance training with insensitive vibrotactile neurofeedback
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

Change in the tendency to fall in stance and gait conditions - measured using VertiGuard® RT during the 14 test situations of geriatric standard balance deficit tests after 6 weeks of treatment (4 weeks only EGb761® plus 2 weeks of EGb761® und balance training)

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Secondary Outcome

a) Tendency to fall in equilibrium situations between visit 2 and visit 3, and visit 2 and visit 5

b) Subjective impairment due to vertigo
- Total score of Dizziness Handicap Inventory
- Subscores of Dizziness Handicap Inventory for the functional, physical and emotional impairment

c)Hearing ability
- Threshold of hearing at frequencies 0.5, 1, 2, 4, and 8 kHz in the pure tone audiometry

d) Cognitive capacity
- Trail Making Test, duration of test A (s)
- Trail Making Test, duration of test B (s)
- Difference Test B - Test A

e)Safety and tolerability

- After 4 weeks of treatment with EGb761® (Visit 3)
- After 6 weeks treatment ( 4 weeks only EGb761®, 2 weeks EGb761® and balance exercise (visit 4)
- 6 weeks after end of balance training (12 weeks EGB761® inclusive 2 weeks balance exercise) (visit 5)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2015/01/07
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Subjective chronic vertigo for > 3 months
2. Dizziness Handicap Inventory (DHI) score > 25
3. geriatric standard balance deficit test determined risk of falling > 40%
4. Written informed consent
5. Willingness and ability to participate in all study specific tasks

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Exclusion Criteria

1. Hemorrhagic diatheses, coagulation disorder, ulcus ventriculi or duodeni
2. Conditions which may impair resorption
3. Severe or acute general disorder within the last 4 weeks
4. Acute or chronic otologic, neurologic or psychiatric disease during the last 12 months except presbyvertigo such as depression, stroke, TIA, Parkinson’s disease, Alzheimer’s disease, seizures, traumatic brain injury, cerebral hemorrhage, multiple sclerosis, sudden idiopathic hearing loss, Menière’s disease, benign positional vertigo
5. Severe or unstable medical disorders such as
a. Malignoma with exception carcinoma in situ, adequately treated basal cell carcinoma or curative treated malignom more than 3 years ago
b. Uncontrolled arterial hypertension
c. Uncontrolled Diabetes mellitus
d. Known cardiac arrhythmia (Lown classes IVb and V)
e. Heart failure NYHA III or IV
f. Active bacterial infection
g. Severe coronary heart disease (State IV Canadian Cardiovascular Society), instable angina pectoris, heart attack within the last 6 months
6. Presence of clinically significant ECG or laboratory abnormalities
7. Hypersensitivity to one of the ingredients of the study drug
8. Current substance abuse or addiction or history thereof
9. Participation in another clinical trial during the past 12 weeks
10. Concomitant medication out of one of the following substant classes
a. anticoagulants (heparin, vitamine-K-antagonists, dabigatran, apixaban or rivaroxaban)
b. Anti-dementia drugs or nootropics
c. Benzodiazepines
11. Intake of any Ginkgo biloba preparation within the last 12 weeks
12. Planned surgery or hospital stay during study
13. Other factors which call into question the study participation (e.g. lack of understanding of nature and scope of the study, insufficient knowledge of German language)
14 people who are located in an institution on judicial or administrative order
15. Persons who are dependent from the sponsor or investigator

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Addresses

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    • Dr. Willmar Schwabe GmbH &Co. KG
    • Willmar- Schwabe- Str. 4
    • 76227  Karlsruhe
    • Germany
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    • Dr. Willmar Schwabe GmbH & Co. KG
    • Mr.  Dr.  Martin  Burkart 
    • Bunsenstraße 6-10
    • 76275  Ettlingen
    • Germany
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    • Dr. Willmar Schwabe GmbH & Co. KG
    • Mr.  Dr.  Martin  Burkart 
    • Bunsenstraße 6-10
    • 76275  Ettlingen
    • Germany
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Sources of Monetary or Material Support

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    • Dr. Willmar Schwabe GmbH &Co. KG
    • Willmar- Schwabe- Str. 4
    • 76227  Karlsruhe
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/06/19
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Trial Publications, Results and other Documents

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