Study Stopped
The number of responders in the test sessions was too low.
Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation
indiTMS
1 other identifier
interventional
22
1 country
1
Brief Summary
In the first visit a magnetic resonance imaging measurement will be done for the use of a neuronavigation System with the aim to control for stable coil position over the course of the trial. EEG positions CP5/CP6 will be used for positioning the coil. Two test sessions will examine the temporary reductions in tinnitus loudness after 1Hz, 10Hz, 20Hz and 0.1Hz rTMS as control condition over left and right temporo-parietal junction accompanied by electroencephalography. For the two-week treatment three arms will be evaluated: standard treatment (1Hz left-sided) in the groups with and without temporary reductions in test sessions and the best protocol as elicited in test sessions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
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
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedDecember 19, 2019
December 1, 2019
7 months
May 16, 2019
December 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TFI
Tinnitus Functional Index
2 weeks
Secondary Outcomes (7)
TFI
12 weeks
Mini-TQ
12 weeks
THI
12 weeks
Tinnitus Severity
12 weeks
MDI
12 weeks
- +2 more secondary outcomes
Study Arms (3)
individualized rTMS
EXPERIMENTALTreatment with the best (highest reduction in tinnitus loudness, most reliable, superior to control condition, most tolerable) protocol as obtained in the test sessions (left vs. right temporoparietal junction, 1Hz, 10Hz, 20Hz, 0.1Hz as active control condition).
standard rTMS in responders
ACTIVE COMPARATORTreatment with standard protocol: left-sided 1Hz in the group of patients who showed temporary reductions in tinnitus loudness in test sessions.
standard rTMS in non-responders
ACTIVE COMPARATORTreatment with standard protocol: left-sided 1Hz in the group of patients who did not show temporary reductions in tinnitus loudness in test sessions.
Interventions
Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation * 2000 pulses * intensity of 110% resting motor threshold * 10 sessions (daily from Monday to Friday) * positioning of coil according to EEG position CP5/CP6
Eligibility Criteria
You may qualify if:
- chronic tinnitus (\> 6 months)
- at least moderate tinnitus distress
- no or consistent medication
- no or consistent Treatments
- residence in Germany and German speaking
You may not qualify if:
- objective tinnitus
- serious and not stable illness (e.g. acute psychosis, severe depression or substance dependence, epilepsy, brain tumor)
- meeting the contraindications for transcranial magnetic stimulation or magnetic resonance imaging (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump)
- neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma)
- addictive disorder with consumption in the last two years
- regular intake of benzodiazepines
- participation in another study parallel to the trial
- pregnancy or breastfeeding period
- psychiatric confinement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, 93053, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Berthold Langguth
University of Regensburg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Center II and out-patient clinic of the Department of Psychiatry and Psychotherapy
Study Record Dates
First Submitted
May 16, 2019
First Posted
May 21, 2019
Study Start
May 1, 2019
Primary Completion
November 30, 2019
Study Completion
November 30, 2019
Last Updated
December 19, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share