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

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.
Overall Study
STARTED
1
Overall Study
COMPLETED
1
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

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.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
65 years
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
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
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: End of treatment course - 5 days

Population: single patient

Clinical Global Improvement Scale (0-7 scale where 0=not assessed, 1=Very much improved, and 7= Very much worse

Outcome measures

Outcome measures
Measure
TMS Treatment (Open Label, N = 1)
n=1 Participants
TMS for tinnitus: Targeted stimulation to decrease tinnitus symptom severity.
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

Aaron Boes

University of Iowa

Phone: 319-353-8587

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place