A Feasibility Study Assessing the Effectiveness of rTMS in Tinnitus
A Feasibility Study to Assess the Effectiveness of Different Modalities of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
1 other identifier
interventional
40
1 country
1
Brief Summary
Tinnitus is a common problem which can have a severe impact on quality of life and for which there is no truly successful treatment available. Repetitive transcranial magnetic stimulation (rTMS) is a method of stimulating the brain through the application of a magnetic field in a series of rapid pulses and may be a valuable treatment for patients with tinnitus. The overall aim of this research is to see if patients with tinnitus benefit from treatment with rTMS, and in particular whether one type (continuous theta burst) is more effective than other variations of rTMS. Prior to developing a definitive study to address this area a feasibility study needs to be performed. The proposed feasibility study aims to determine outcomes necessary to enable development of a definitive study in the future. 40 patients suffering with idiopathic tinnitus will be randomised into 2 groups, a control group receiving a sham treatment, and an active treatment group receiving theta-burst rTMS on 5 consecutive days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
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
First Submitted
Initial submission to the registry
June 27, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedNovember 2, 2016
November 1, 2016
1.8 years
June 27, 2014
November 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in tinnitus severity following treatment with rTMS
The primary outcome measure for the definitive trial is the improvement in tinnitus severity following treatment with theta burst rTMS compared to control as demonstrated by change in Tinnitus Functional Index (TFI) scores. Assessed on completion of treatment and at 1 week and 1 month following.
3 months
Secondary Outcomes (5)
The number of patients willing to complete the trial
3 months
Confirm acceptability of trial design to participants
3 months
Determine success of sham intervention
3 months
Success of assessment methods
3 months
Sample size calculation
3 months
Study Arms (2)
theta-burst rTMS
ACTIVE COMPARATORActive treatment will consist of sessions of continuous theta-burst rTMS on consecutive days for 5 days. This will be delivered with a circular coil to the temporal scalp region overlying the auditory cortex, contralateral to the symptomatic side in unilateral tinnitus and to the left side in bilateral tinnitus. The treatment protocol will consist of treatment at 80% of individual motor threshold (established at the first treatment session) for 600 pulses of 40 seconds duration, which will be repeated after 15 minutes. Each patient will receive 1200 pulses per day.
Control arm
SHAM COMPARATORThe control (sham) stimulation will consist of stimulating with the rTMS coil held at right angles to the participants' head. This will result in no active stimulation of brain tissue but would feel similar to the patient. Each treatment session will therefore last approximately 20 minutes.
Interventions
Active treatment will consist of sessions of continuous theta-burst rTMS on consecutive days for 5 days. This will be delivered with a circular coil to the temporal scalp region overlying the auditory cortex, contralateral to the symptomatic side in unilateral tinnitus and to the left side in bilateral tinnitus. The treatment protocol will consist of treatment at 80% of individual motor threshold (established at the first treatment session) for 600 pulses of 40 seconds duration, which will be repeated after 15 minutes. Each patient will receive 1200 pulses per day.
Eligibility Criteria
You may qualify if:
- Age over 18 years
- Persistent unilateral or bilateral subjective tinnitus
You may not qualify if:
- Epilepsy
- Severe or profound hearing loss
- Patients taking vestibular sedatives, antipsychotic, anxiolytic, antiepileptic and ototoxic medications.
- Ear infections or discharge
- History of ear surgery
- History of noise trauma
- Excess alcohol consumption
- Meniere's disease
- VIII nerve tumour
- Bells palsy
- Ramsay-Hunt Syndrome
- Post-meningitis hearing loss and tinnitus
- Active psychiatric conditions
- Congenital or syndromal associations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaydip Ray, PhD
Sheffield Teaching Hospitals NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2014
First Posted
October 21, 2014
Study Start
September 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
November 2, 2016
Record last verified: 2016-11