NCT00878696

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
Last Updated

April 9, 2009

Status Verified

April 1, 2009

Enrollment Period

8 months

First QC Date

April 7, 2009

Last Update Submit

April 8, 2009

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • VAS visual analogue scale

    immediately before and immediately after single session TMS

Study Arms (1)

Tinnitus

Tinnitus patients

Procedure: TMS transcranial magnetic stimulation

Interventions

TMS transcranial magnetic stimulationPROCEDURE

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.

Tinnitus

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 9, 2009

Study Start

January 1, 2007

Primary Completion

September 1, 2007

Study Completion

April 1, 2008

Last Updated

April 9, 2009

Record last verified: 2009-04

Locations

BE(1)