Influence of Treatment Duration and Stimulation Frequency on rTMS in Chronic Tinnitus
1 other identifier
interventional
90
1 country
1
Brief Summary
Patients receive two weeks of treatment (prefrontal high-frequency and bilateral low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After two weeks of treatment they can decide if they want to quit the treatment or if they want to proceed with the treatment for another two weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 8, 2016
CompletedFirst Posted
Study publicly available on registry
January 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2018
CompletedJune 18, 2018
June 1, 2018
2.4 years
January 8, 2016
June 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in tinnitus questionnaire
change in tinnitus questionnaire
week12
Secondary Outcomes (6)
change in tinnitus questionnaire
week2, week3, week4, week12
change in tinnitus handicap inventory
week2, week3, week4, week12
change in tinnitus numeric rating scales
week2, week3, week4, week12
change in major depression inventory
week2, week3, week4, week12
change in clinical global impression
week2, week3, week4, week12
- +1 more secondary outcomes
Study Arms (4)
standard multisite four weeks
EXPERIMENTALCombined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks
high-frequency multisite four weeks
EXPERIMENTALCombined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks
standard multisite two weeks
EXPERIMENTALCombined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks
high-frequency multisite two weeks
EXPERIMENTALCombined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks
Interventions
Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients continue treatment after two weeks for further two weeks of treatment (20 treatment days).
Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients continue treatment after two weeks for further two weeks of treatment (20 treatment days).
Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients discontinue treatment after two weeks (10 treatment days).
Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients discontinue treatment after two weeks (10 treatment days).
Eligibility Criteria
You may qualify if:
- written informed consent
- duration of tinnitus more than 6 months
- bothersome chronic tinnitus
You may not qualify if:
- not stable internal, mental, and neurological diseases
- contraindication for rTMS (pacemaker, metal implants, pregnancy, epilepsy, status post severe craniocerebral injury )
- uninvolvement in other treatment studies for tinnitus at the same time
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Regensburg- Dept of Psychiatry
Regensburg, 93053, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Berthold Langguth
University of Regensburg, Department of Psychiatry
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
- M.D., Ph.D.
Study Record Dates
First Submitted
January 8, 2016
First Posted
January 12, 2016
Study Start
January 1, 2016
Primary Completion
May 23, 2018
Study Completion
May 23, 2018
Last Updated
June 18, 2018
Record last verified: 2018-06