Trial Outcomes & Findings for Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus (NCT NCT00329524)

Results Overview

Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

After active treatment week

Results posted on

2015-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Active Versus Sham TMS Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Versus Sham TMS n=5 Participants Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: After active treatment week

Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx

Outcome measures

Outcome measures
Measure	Active Versus Sham TMS n=5 Participants Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
Change in PET Asymmetry Index	1.2 ratio Standard Deviation 2.3

SECONDARY outcome

Timeframe: Immediately after treatment

Population: per protocol

Change in simple auditory reaction time after treatment

Outcome measures

Outcome measures
Measure	Active Versus Sham TMS n=5 Participants Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
Psychomotor Vigilance	-30 milliseconds Standard Deviation 18.27

SECONDARY outcome

Timeframe: immediately following active and sham TMS

Rating of tinnitus loudness using a scale of 0-100 for

Outcome measures

Outcome measures
Measure	Active Versus Sham TMS n=5 Participants Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx	2.5 analog rating Standard Deviation 1.2

Adverse Events

Active Versus Sham Treatment

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

John Dornhoffer, MD

UAMS Department of Otolaryngology

Phone: 501-686-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place