Priming stimulation as an enhancement of low-frequency repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of tinnitus
| ISRCTN | ISRCTN03638520 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03638520 |
| Protocol serial number | 01/194 |
| Sponsor | Regensburg District Clinic (Bezirksklinikum Regensburg) (Germany) |
| Funder | Tinnitus Research Initative (Germany) |
- Submission date
- 14/08/2007
- Registration date
- 23/08/2007
- Last edited
- 31/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Berthold Langguth
Scientific
Scientific
Universitaetsstr.86
Regensburg
93053
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized, controlled, parallel-design study. |
| Secondary study design | Randomised controlled trial |
| Scientific title | Priming stimulation as an enhancement of low-frequency repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of tinnitus |
| Study objectives | 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(s) | Ethics Committee of the University of Regensburg, University Clinic Regensburg (ref: 01/194). Approved on 19.12.2001 (amendment on 19.2.2007). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Change in tinnitus severity according to the Tinnitus Questionnaire of Goebel and Hiller (baseline vs day 12). |
| Key secondary outcome measure(s) |
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). |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 32 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Universitaetsstr.86
Regensburg
93053
Germany
93053
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2008 | 31/12/2020 | Yes | No |
Editorial Notes
31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
