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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00878696
Other study ID # ITBTMS
Secondary ID
Status Completed
Phase N/A
First received April 7, 2009
Last updated April 8, 2009
Start date January 2007
Est. completion date April 2008

Study information

Verified date April 2009
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Observational

Clinical Trial Summary

Transcranial magnetic stimulation (TMS) is already broadly used in different areas of neuroscience research. Last year, special attention was drawn to TMS in tinnitus. The aim of the researchers' study is to investigate the stimulation characteristics of TMS in tinnitus patients, in particularly the effect of tonic and burst stimulation of the superior temporal lobe.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date April 2008
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 78 Years
Eligibility Inclusion Criteria:

- Patients presented to our Multidisciplinary Tinnitus Clinic with tinnitus as a main complaint.

Exclusion Criteria:

- Patients with known history of epilepsy, pacemakers, cochlear implants, neurostimulators or intracerebral pathology were excluded from the study.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
TMS transcranial magnetic stimulation
200 pulses of tonic TMS (see Graph 1) were administered with an intensity at 50% of the maximal TMS device output (50%DO). The frequency of the tonic pulses was randomly chosen between 1Hz, 5Hz, 10Hz or 20Hz. Burst stimulation was delivered at a burst frequency of 5, 10 or 20Hz. Each burst consisted of 3, 5 or 10 pulses. The individual pulse rate within a burst was 50 or 100Hz.

Locations

Country Name City State
Belgium Antwerp University Hospital Edegem Antwerp

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary VAS visual analogue scale immediately before and immediately after single session TMS No
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