Trial Outcomes & Findings for Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation (NCT NCT03699826)
NCT ID: NCT03699826
Last Updated: 2023-07-11
Results Overview
Clinical Global Improvement Scale (0-7 scale where 0=not assessed, 1=Very much improved, and 7= Very much worse
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
End of treatment course - 5 days
Results posted on
2023-07-11
Participant Flow
Participant milestones
| Measure |
TMS for Tinnitus
TMS for tinnitus: Open label study of neuro-navigated transcranial magnetic stimulation evaluating different stimulation sites and different stimulation protocols to decrease tinnitus symptom severity. Our goal was to evaluate whether a trial-and-error targeting session could be useful in selecting the stimulation site and frequency of stimulation before conducting daily treatments.
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|---|---|
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Overall Study
STARTED
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1
|
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Overall Study
COMPLETED
|
1
|
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Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Experimental Tinnitus Treatment With Transcranial Magnetic Stimulation
Baseline characteristics by cohort
| Measure |
TMS for Tinnitus
n=1 Participants
TMS for tinnitus: Open label study of neuro-navigated transcranial magnetic stimulation evaluating different stimulation sites and different stimulation protocols to decrease tinnitus symptom severity. Our goal was to evaluate whether a trial-and-error targeting session could be useful in selecting the stimulation site and frequency of stimulation before conducting daily treatments.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: End of treatment course - 5 daysPopulation: single patient
Clinical Global Improvement Scale (0-7 scale where 0=not assessed, 1=Very much improved, and 7= Very much worse
Outcome measures
| Measure |
TMS Treatment (Open Label, N = 1)
n=1 Participants
TMS for tinnitus: Targeted stimulation to decrease tinnitus symptom severity.
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|---|---|
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Clinical Improvement
|
4 score on a scale
|
Adverse Events
TMS Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place