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
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