Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus

NCT02283216 | Withdrawn DMC

• 1 other identifier: 1409M53708
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate different stimulation parameters for a new noninvasive approach for modulating the brain that could potentially be beneficial for decreasing tinnitus perception. The new approach is called Multimodal Synchronization Therapy (mSync). mSync uses a combination of acoustic stimulation played through headphones and low levels of electrical current delivered via electrodes placed on the surface of different body regions. The timing interval between the acoustic and body stimulation is varied in order to cause different types of changes in the brain. In addition to acoustic and body stimulation, noninvasive cortical stimulation will also be presented as part of mSync to attempt to further modulate or decrease the tinnitus percept. Cortical stimulation will be performed by placing a magnetic coil over a spot on the head and sending a brief magnetic pulse that can travel through the skin and bone to create electrical current inside the head. For this study, different body locations as well as specific timing intervals among acoustic, body, and cortical stimulation will be investigated to identify appropriate parameters that can modulate and potentially decrease tinnitus perception. Different mSync parameters will be investigated across multiple testing sessions (up to 16 weekly sessions) and the tinnitus percept will be closely monitored throughout the study.

Conditions

Tinnitus

Keywords

neuromodulation; noninvasive; plasticity; transcranial magnetic stimulation; hearing; hyperacusis

Outcome Measures

Primary Outcomes (2)

• Change in Tinnitus Functional Index Questionnaire Score

  A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.

  Change from baseline score at 1 week after testing paradigm

• Change in Minimal Masking Level

  A narrowband noise (from 2-12 kHz) is presented to the tinnitus ear and the minimum sound level (in decibel sound pressure level, decibel SPL) is determined that completely masks the tinnitus percept.

  Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm

Secondary Outcomes (5)

• Change in Tinnitus Handicap Inventory Questionnaire Score

  Change from baseline score at 1 week after testing paradigm

• Change in Tinnitus Rating (0-10, 10 being worst)

  Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm

• Change in Tinnitus Subjective Description

  Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm

• Change in Tinnitus Matching (pitch and loudness)

  Change in baseline pitch and loudness at an expected average of 1.5 hours after testing paradigm

• Daily Tinnitus Journal Entries

  0, 1, 2, 3, 4, 5, 6, 7 days post-testing paradigm

Study Arms (1)

Acoustic, Body, Cortical

EXPERIMENTAL

Acoustic corresponds to noise sound stimulation. Body corresponds to body electrical stimulation. Cortical corresponds to transcranial magnetic stimulation. Acoustic is presented together with body and cortical stimulation. Different body locations and timing among acoustic, body, and cortical stimulation are presented across testing sessions.

Device: noise sound stimulation (Tucker-Davis Technologies); Device: body electrical stimulation (Digitimer device); Device: transcranial magnetic stimulation (Magstim)

Interventions

noise sound stimulation (Tucker-Davis Technologies) DEVICE

Band-limited white noise stimulus, comfortable loudness level, presented via headphones or earphones with Tucker-Davis Technologies device.

Acoustic, Body, Cortical

body electrical stimulation (Digitimer device) DEVICE

Single pulse electrical stimulation on different body regions, comfortable current level, presented via surface pads or clips with Digitimer device.

Acoustic, Body, Cortical

transcranial magnetic stimulation (Magstim) DEVICE

Single pulse magnetic stimulation over frontal cortex, comfortable level at 110% resting motor threshold, presented via magnetic coil with Magstim device.

Acoustic, Body, Cortical

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have subjective, non-pulsatile, and bothersome tinnitus
• Will not start any new tinnitus treatment during the study
• Ability to give informed consent and understand study objectives in English
• Willing and able to understand and comply with all study-related procedures

You may not qualify if:

• Substantial hearing loss or hyperacusis that may interfere with the study
• Medical history of other ear or brain disorders, history of seizures, or currently using any medication or treatments that can cause or increase the chances of seizures
• Any implanted medical or metal device, such as a pacemaker, aneurysm clip, or cochlear implant
• Pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children need extra protection for their safety)
• Any handicap that prevents the subject from reliably performing the tests

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Nils Hasselmo Hall, 6-105

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tinnitus; Hyperacusis

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Hubert Lim, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: November 5, 2014
• Study Start: June 1, 2015
• Primary Completion: September 13, 2017
• Study Completion: September 13, 2017
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

US (1)