Trial Outcomes & Findings for Transcranial Magnetic Stimulation for Tinnitus (NCT NCT01104207)
NCT ID: NCT01104207
Last Updated: 2017-03-29
Results Overview
The TFI is a 25-item questionnaire that assesses tinnitus severity. The possible range of scores for the TFI is 0 to 100, with higher scores indicating more severe tinnitus.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
26 weeks post-treatment
Results posted on
2017-03-29
Participant Flow
Participant milestones
| Measure |
Arm 1
For half of the subjects, rTMS will be delivered to one side of the head.
repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception.
|
Arm 2
For half of the subjects, placebo rTMS will be delivered to one side of the head.
placebo rTMS: placebo rTMS
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Magnetic Stimulation for Tinnitus
Baseline characteristics by cohort
| Measure |
Arm 1
n=35 Participants
For half of the subjects, rTMS will be delivered to one side of the head.
repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception.
|
Arm 2
n=35 Participants
For half of the subjects, placebo rTMS will be delivered to one side of the head.
placebo rTMS: placebo rTMS
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Tinnitus Functional Index
|
44.8 units on a scale
STANDARD_DEVIATION 19.4 • n=5 Participants
|
40.6 units on a scale
STANDARD_DEVIATION 22.2 • n=7 Participants
|
42.7 units on a scale
STANDARD_DEVIATION 20.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeks post-treatmentThe TFI is a 25-item questionnaire that assesses tinnitus severity. The possible range of scores for the TFI is 0 to 100, with higher scores indicating more severe tinnitus.
Outcome measures
| Measure |
Arm 1
n=32 Participants
For half of the subjects, rTMS will be delivered to one side of the head.
repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception.
|
Arm 2
n=32 Participants
For half of the subjects, placebo rTMS will be delivered to one side of the head.
placebo rTMS: placebo rTMS
|
|---|---|---|
|
Change in Tinnitus Functional Index (TFI) Score
|
-13.8 units on TFI scale; change from baseline
Standard Deviation 15.2
|
-2.9 units on TFI scale; change from baseline
Standard Deviation 15.8
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
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