Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/8/2019 |
| Start Date: | December 10, 2018 |
| End Date: | December 2023 |
There are numerous conditions that may benefit from TMS but they lack definitive data from
clinical trials with sufficient scientific rigor, which includes large, multi-site,
randomized sham-controlled trials. This is the status for a variety of psychiatric and
neurological disorders such as tinnitus, central pain, movement disorders, stroke
rehabilitation, obsessive compulsive disorders, anxiety, schizophrenia, and addiction. In
certain instances there may be sufficient evidence supporting the treatment efficacy of TMS
that it is reasonable to offer TMS as an off-label treatment, a term for clinical treatments
that have not received FDA approval but may nonetheless be helpful for patients. In other
cases there is such a paucity of clinical trial data that the use of therapeutic TMS is less
appropriate as a clinical treatment that the patient is charged for out of pocket and may
cost several thousand dollars, but is better suited for clinically-oriented research. This
has the added benefit of potentially helping the patient and providing investigators with
additional information from which to inform future clinical trials. In this study the
investigators propose to use TMS to treat tinnitus, for which few other treatments currently
exist. Tinnitus affects approximately 1% of the population and can be debilitating for
patients. Recent studies have shown some promise in reducing symptoms through
neuromodulation, but results are variable and more research is needed to improve treatment
protocols. The investigators plan to contribute to this body of research by taking an
evidence-based approach to test whether TMS is effective at reducing symptoms of tinnitus.
Each subject's MRI will be used to perform neuronavigated TMS stimulations while documenting
changes in symptom severity with self-report questionnaires and symptom severity scales. If
it is determined that a stimulation protocol is effective, 1-2 weeks of daily treatments will
be scheduled as part of that subject's personalized treatment plan.
clinical trials with sufficient scientific rigor, which includes large, multi-site,
randomized sham-controlled trials. This is the status for a variety of psychiatric and
neurological disorders such as tinnitus, central pain, movement disorders, stroke
rehabilitation, obsessive compulsive disorders, anxiety, schizophrenia, and addiction. In
certain instances there may be sufficient evidence supporting the treatment efficacy of TMS
that it is reasonable to offer TMS as an off-label treatment, a term for clinical treatments
that have not received FDA approval but may nonetheless be helpful for patients. In other
cases there is such a paucity of clinical trial data that the use of therapeutic TMS is less
appropriate as a clinical treatment that the patient is charged for out of pocket and may
cost several thousand dollars, but is better suited for clinically-oriented research. This
has the added benefit of potentially helping the patient and providing investigators with
additional information from which to inform future clinical trials. In this study the
investigators propose to use TMS to treat tinnitus, for which few other treatments currently
exist. Tinnitus affects approximately 1% of the population and can be debilitating for
patients. Recent studies have shown some promise in reducing symptoms through
neuromodulation, but results are variable and more research is needed to improve treatment
protocols. The investigators plan to contribute to this body of research by taking an
evidence-based approach to test whether TMS is effective at reducing symptoms of tinnitus.
Each subject's MRI will be used to perform neuronavigated TMS stimulations while documenting
changes in symptom severity with self-report questionnaires and symptom severity scales. If
it is determined that a stimulation protocol is effective, 1-2 weeks of daily treatments will
be scheduled as part of that subject's personalized treatment plan.
1. Consent patients that have been referred to the Noninvasive Brain Stimulation Clinic at
the University of Iowa.
2. Patients will complete the following before any treatments occur: Tinnitus Intake
Questionnaire, Tinnitus Functional Index, Tinnitus Questionnaires, Iowa Tinnitus Primary
Function, Clinical Global Improvement Scale.
3. Patients may undergo audiological assessment if they have not already been tested prior
to the study.
4. Patients will be required to obtain an MRI prior to treatment to aid in neuronavigated
stimulation unless there is have access to a previous clinical MRI for this purpose.
5. MRI images will be loaded into BrainSight or Localite, which are both frameless
stereotactic systems for MRI-guided TMS localization. If no MRI is acquired, the
subject's head will be transformed to MNI standard space within the software.
Neuronavigation allows us to place specific stimulation targets onto each subjects's
MRI. For this study, the investigators will be targeting left dorsolateral prefrontal
cortex, auditory cortices, and auditory association cortices; all targets are placed
anatomically by a neurologist. Infrared trackers on the subject's head and TMS coil
allow for neuronavigated stimulation of anatomical targets on the cortex with millimeter
precision.
6. The motor threshold of the subject will be assessed, which is the intensity of TMS
required to elicit motor evoked potentials from the hand 50% of the time.
7. Subjects will be fitted with an EEG cap to record neural activity before, during, and
after the initial test session.
8. Single TMS pulses or brief trains of repetitive TMS lasting a few seconds will be
administered at 80 - 120% of motor threshold to targeted regions of the cerebral cortex
and cerebellum. A typical experiment will last 30 minutes to 2 hours. The patients are
told they can stop the experiment at any time.
9. After each stimulation, patients will be asked to rate any changes in symptom severity
and whether any side effects were experienced (Tinnitus Questionnaires, Clinical Global
Improvement Scale).
10. After the treatment session, the TMS pulse locations will be related to changes in
symptom severity as measured by self-report. If any stimulation treatments were
successful in reducing symptom severity, a treatment plan for that target will be
discussed and follow-up treatments may be scheduled.
11. Follow up treatments will vary between patients but will typically consist of daily
treatments for up to 4 weeks or until treatment response is sustained. The patient can
withdraw from follow treatments at any time. Patients will be asked to complete the
following at these visits: Tinnitus Functional Index, Tinnitus Questionnaires, Iowa
Tinnitus Primary Function, Clinical Global Improvement Scale.
the University of Iowa.
2. Patients will complete the following before any treatments occur: Tinnitus Intake
Questionnaire, Tinnitus Functional Index, Tinnitus Questionnaires, Iowa Tinnitus Primary
Function, Clinical Global Improvement Scale.
3. Patients may undergo audiological assessment if they have not already been tested prior
to the study.
4. Patients will be required to obtain an MRI prior to treatment to aid in neuronavigated
stimulation unless there is have access to a previous clinical MRI for this purpose.
5. MRI images will be loaded into BrainSight or Localite, which are both frameless
stereotactic systems for MRI-guided TMS localization. If no MRI is acquired, the
subject's head will be transformed to MNI standard space within the software.
Neuronavigation allows us to place specific stimulation targets onto each subjects's
MRI. For this study, the investigators will be targeting left dorsolateral prefrontal
cortex, auditory cortices, and auditory association cortices; all targets are placed
anatomically by a neurologist. Infrared trackers on the subject's head and TMS coil
allow for neuronavigated stimulation of anatomical targets on the cortex with millimeter
precision.
6. The motor threshold of the subject will be assessed, which is the intensity of TMS
required to elicit motor evoked potentials from the hand 50% of the time.
7. Subjects will be fitted with an EEG cap to record neural activity before, during, and
after the initial test session.
8. Single TMS pulses or brief trains of repetitive TMS lasting a few seconds will be
administered at 80 - 120% of motor threshold to targeted regions of the cerebral cortex
and cerebellum. A typical experiment will last 30 minutes to 2 hours. The patients are
told they can stop the experiment at any time.
9. After each stimulation, patients will be asked to rate any changes in symptom severity
and whether any side effects were experienced (Tinnitus Questionnaires, Clinical Global
Improvement Scale).
10. After the treatment session, the TMS pulse locations will be related to changes in
symptom severity as measured by self-report. If any stimulation treatments were
successful in reducing symptom severity, a treatment plan for that target will be
discussed and follow-up treatments may be scheduled.
11. Follow up treatments will vary between patients but will typically consist of daily
treatments for up to 4 weeks or until treatment response is sustained. The patient can
withdraw from follow treatments at any time. Patients will be asked to complete the
following at these visits: Tinnitus Functional Index, Tinnitus Questionnaires, Iowa
Tinnitus Primary Function, Clinical Global Improvement Scale.
Inclusion Criteria:
- tinnitus diagnosis
Exclusion Criteria:
- have epilepsy or a family history of epilepsy
- have implanted metal in or near their head
- have any history of brain injury or stroke
- have a tinnitus handicap inventory score of <38 (less than moderate handicap)
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