EUCTR2014-000303-28-DE
Active, not recruiting
Phase 1
Multi-center, prospective, controlled, randomized, single-blinded study to evaluate the efficacy of vibrotactile neuro-feedback additionally to intake of Ginkgo biloba special extract EGb 761® for the treament of presby vertigo.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Presby Vertigo
- Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Men and women aged 60 or older
- •2\. subjective chronic vertigo for \> 3 months
- •3\. Dizziness Handicap Inventory (DHI) score \> 25
- •4\. Geriatrischen Standard Balance Defizit Test determined risk of falling \> 40 %
- •5\. Written informed consent
- •6\. Willingness and ability to participate all stuy specific tasks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 20
Exclusion Criteria
- •1\. hemorrhagic diatheses, coagulation disorder, Ulcus ventriculi or duodeni
- •2\. Diseases affecting resorption
- •3\. Severe or acute general diseases within the last 4 weeks
- •4\. Acute or chronic otologic, neurologic or psychiatric diseases within the last 12 months except age\-related vertigo, i.e. depression, stroke, TIA, Parkinson\-disease, Alzheimer\-disease, seizure disorders, craniocerebral trauma, brain haemorrhage, Multiple sklerosis, ISSHL, morbus menière, benign positional vertigo
- •5\. Severe or instable internal disorders such as
- •a. Malignoma with the exception of 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\-classification IVb and V)
- •e. Heart failure NYHA III or IV
Outcomes
Primary Outcomes
Not specified
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