Condition category
Ear, Nose and Throat
Date applied
14/08/2007
Date assigned
23/08/2007
Last edited
04/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Berthold Langguth

ORCID ID

Contact details

Universitaetsstr.86
Regensburg
93053
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01/194

Study information

Scientific title

Acronym

Study hypothesis

Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Experimental data indicate that the depressant effect of low-frequency rTMS can be enhanced by high frequency priming stimulation. In the proposed study we investigate whether priming improves therapeutic efficacy of low-frequency rTMS in a clinical application.

Ethics approval

Ethics Committee of the University of Regensburg, University Clinic Regensburg (ref: 01/194). Approved on 19.12.2001 (amendment on 19.2.2007).

Study design

Randomized, controlled, parallel-design study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic tinnitus

Intervention

Experimental intervention: Low frequency rTMS over the left auditory cortex with priming stimulation: 6Hz (90% motor threshold, 960 stimuli) followed by low frequency rTMS (110% motor threshold, 1Hz, 1040 stimuli/day) 5 days a week for two weeks.
Control intervention: Standard protocol of low frequency rTMS (110% motor threshold, 1Hz, 2000 stimuli/day), 5 days a week for two weeks.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in tinnitus severity according to the Tinnitus Questionnaire of Goebel and Hiller (baseline vs day 12).

Secondary outcome measures

Reduction of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller (TQ; THI) during the follow-up period (screening versus baseline versus days 18, 59, 90).

Overall trial start date

01/03/2003

Overall trial end date

31/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female and male in- and outpatients
2. Age 18-70 years
3. Diagnosis of subjective chronic tinnitus
4. Duration of tinnitus more than 6 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Participant exclusion criteria

1. Patients with conductive hearing loss of more than 15dB
2. Objective tinnitus
3. Treatable otologic disorder
4. Involvement in other treatments for tinnitus at the same time
5. Clinically relevant psychiatric comorbidity
6. Clinically relevant unstable internal or neurological comorbidity
7. History of or evidence of significant brain malformation or neoplasm, head injury
8. Cerebral vascular events
9. Neurodegenerative disorder affecting the brain or prior brain surgery;
10. Factors militating against the use of TMS (e.g. cardiac pace makers or other metal implants)
11. Pregnancy

Recruitment start date

01/03/2003

Recruitment end date

31/07/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Universitaetsstr.86
Regensburg
93053
Germany

Sponsor information

Organisation

Regensburg District Clinic (Bezirksklinikum Regensburg) (Germany)

Sponsor details

Universitaetsstr. 84
Regensburg
93053
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.bkr-regensburg.de/

Funders

Funder type

Other

Funder name

Tinnitus Research Initative (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes