University of Arkansas Looking for rTMS Study Participants

erik

Member
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May 8, 2012
1,601
Washington State, USA
Tinnitus Since
04/15/2012 or earlier?
Cause of Tinnitus
Most likely hearing loss
http://www.arkansasonline.com/news/2015/feb/10/participants-sought-uams-tinnitus-study/?f=latest

University of Arkansas for Medical Sciences researchers are studying improvements to an experimental treatment of ringing in the ears, a condition known as tinnitus, and are recruiting those with symptoms for the study.

The study involves transcranial magnetic stimulation, a noninvasive treatment which has been approved by the U.S. Food and Drug Administration to treat migraines and depression, UAMS said in statement.

Prior studies have shown that transcranial magnetic stimulation reduces tinnitus symptoms in about 50 percent of patients and is well tolerated with no significant side effects, Dr. John Dornhoffer, a co-investigator in the study, said.

The study will enroll 60 men and women from ages 19 to 89 who have experienced mild to moderate tinnitus with mild to moderate hearing loss or no loss for the past six months, the university said.

Those interested in participating are asked to call (501) 526-7988 or email gjbrown@uams.edu.
 
I wrote to the person at that email address -- I don't qualify (yet) because I'm not at least 6 months. But she did provide more study information:

Study Timeline Description:

If a person meets initial screening criteria (by phone), he or she will come to the lab at UAMS in Little Rock for Visit 1, an enrollment/intake visit. Visit 1 takes about 1 hour. At Visit 1, subjects complete a release of information so we may obtain medical records. Our study physician will review records to ensure potential subjects meet study inclusion and will be safe to proceed with study participation. The time required to obtain medical records varies. Once we receive records and the physician clears the subject to proceed, we schedule visit 2.

Visit 2 involves collecting several different baseline measures prior to any treatment with repetitive trans-cranial magnetic stimulation (rTMS). Visit 2 takes about 3 hours.


Following Visit 2, we have test measures to complete over the phone the next 2 days. The test measures take less than 10 minutes on the phone to complete. Our goal is to obtain stable baseline measures of each subject's tinnitus prior to beginning treatment.

After visits 1 and 2 are completed, subjects will begin the Treatment Phase of the study and I schedule the treatment weeks. There are three "treatments weeks," each followed by a minimum of three weeks washout period.


What is a treatment week? A treatment week consists of a subject coming on 4 days in a work week to receive rTMS (either 10Hz active rTMS, sham rTMS, or 1Hz active rTMS). The first and last visit of each week are longer (we do a 1 hour tinnitus assessment prior to treatment and at the end of the treatment week, as well as a 30-min to 1 hour EEG recording at the end of each treatment week). That is, day 1 of the treatment week may take up to 3 hours and day 4 of the treatment week may take up to 3.5 hours. Days 2 and 3 of each treatment week normally last one hour.

Day 1 Tinnitus assessment program (TAP) on computer (~1 hour), rTMS treatment (~1hour)
Day 2 rTMS treatment (1hour)
Day 3 rTMS treatment (1 hour)
Day 4 rTMS treatment (1 hour), TAP (1 hour), Resting EEG (30 – 45 minutes), EEG frequency tuning (20-30 minutes).

After each "treatment week," subjects do not return to the lab for a minimum of 3 weeks. We refer to this as a Washout Period. We contact subjects by phone to complete questionnaires at three time points during each washout period. The phone calls take approximately 10 minutes each.

At this point, we determine if a subject is a responder or non-responder based on comparison of baseline and post treatment test measures. If the subject is not a responder, a final study visit will be scheduled approximately 2 months following the last TMS session. The final visit takes approximately 3 hours.

Subjects who respond to active treatment have the option of continuing in the study to receive optional maintenance treatment. Participation in the maintenance phase of the study adds approximately 10 months to the length of study participation, and involves 6 treatment weeks of active rTMS and 2 treatment weeks of sham rTMS stimulation, each followed by a minimum 3-week washout period. Of course, not in this particular order to keep subjects blinded to treatment condition. We schedule a final study visit approximately 2 months after the last TMS session.​
 
http://www.thv11.com/story/news/loc...s-for-study-on-potential-treatments/23198619/

LITTLE ROCK, Ark. (KTHV) – Researchers at UAMS are studying potential improvements to an experimental treatment of tinnitus (ringing in the ears) and are recruiting people with symptoms.

The study involves the use of transcranial magnetic stimulation (TMS), a noninvasive treatment that the federal Food and Drug Administration (FDA) has approved for other uses, such as migraines and depression, but not tinnitus.

The study will enroll 60 participants, men and women ages 19-89 who have experienced mild-to-moderate tinnitus with mild-to-moderate or no hearing loss for at least the last six months. Those interested in participating may call (501) 526-7988 or email gjbrown@uams.edu.
 

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