Effectiveness of Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Regensburg
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
Study Overview
Brief Summary
Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.
Detailed Description
Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Treatment is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by high frequency rTMS of the left dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether high frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of subjective chronic tinnitus
- •Duration of tinnitus more than 3 months
Exclusion Criteria
- •Objective tinnitus
- •Treatable cause of the tinnitus
- •Involvement in other treatments for tinnitus at the same time
- •Clinically relevant psychiatric comorbidity
- •Clinically relevant unstable internal or neurological comorbidity
- •History of or evidence of significant brain malformation or neoplasm, head injury
- •Cerebral vascular events
- •Neurodegenerative disorder affecting the brain or prior brain surgery;
- •Metal objects in and around body that can not be removed
- •Pregnancy
- •Alcohol or drug abuse
- •Prior treatment with TMS
Arms & Interventions
1
Combined frontal and temporal transcranial magnetic stimulation
Intervention: rTMS - Intervention 1 (Device)
2
Temporal transcranial magnetic stimulation
Intervention: rTMS - Intervention 2 (Device)
Outcomes
Primary Outcomes
tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
Time Frame: Baseline, Day 12
Secondary Outcomes
No secondary outcomes reported