Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

NCT ID: NCT03621735

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2022-07-06

Brief Summary

The goal of the study is to reduce tinnitus (ringing in the ear) loudness and improve the quality of life for those that are affected by tinnitus. This study will enroll subjects who have constant and bothersome tinnitus with no greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss in the tinnitus frequencies. Subjects must also have the ability to alter the loudness or pitch of the ringing in their ears by performing a head, neck, face, or upper body movement. Subjects will be given both the treatment and sham arms (the study will randomly assign which arm is administered first) and will have a washout period of 6 weeks after each arm. The study will take approximately 36 weeks for subjects to complete and will enroll up to 300 individuals.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sham then Active

Active: Bimodal auditory-somatosensory stimulation

Sham: Sham Bimodal auditory-somatosensory stimulation

Subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.

During active treatment, the device will deliver electric somatosensory and auditory stimulation.

Group Type: OTHER

Burst-SCS/sham SCS

Intervention Type: DEVICE

The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.

Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.

For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks.

Active then Sham

Active: Bimodal auditory-somatosensory stimulation

Sham: Sham Bimodal auditory-somatosensory stimulation

Subjects receive both an active treatment and a sham treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.

During active treatment, the device will deliver electric somatosensory and auditory stimulation.

Group Type: OTHER

Sham SCS/Burst-SCS

Intervention Type: DEVICE

Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.

The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.

For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks.

Interventions

Burst-SCS/sham SCS

The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.

Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.

For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks.

Intervention Type: DEVICE

Sham SCS/Burst-SCS

Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.

The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.

For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks.

Intervention Type: DEVICE

Other Intervention Names

St. Jude Medical Invisible Trial System; St. Jude Medical Invisible Trial System

Eligibility Criteria

Inclusion Criteria

• Must report constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
• No greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss at the tinnitus frequencies.
• Must be able to modulate their tinnitus with a somatic maneuver
• Preferably onset of tinnitus less than one year ago, but present for at least 6 months. Tinnitus should be bothersome.
• Absence of retrocochlear pathology/8th nerve lesion
• No participation in a tinnitus treatment regimen within the past six months or participation in the University of Michigan stage 1 clinical trial.

Exclusion Criteria

• Diagnosis of Meniere's disease
• Diagnosis of Semicircular Canal Dehiscence
• Unilateral or bilateral cochlear implant recipients
• Diagnosis of acoustic neuroma
• Evidence of retrocochlear disease
• Certain medications and conditions (will be reviewed at screening)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Susan E. Shore

Professor, Otolaryngology, Molecular and Integrative Physiology; Professor, Biomedical Engineering Kresge Hearing Research Institute The Joseph Hawkins Collegiate Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Shore, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

The University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Jones GR, Martel DT, Riffle TL, Errickson J, Souter JR, Basura GJ, Stucken E, Schvartz-Leyzac KC, Shore SE. Reversing Synchronized Brain Circuits Using Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2315914. doi: 10.1001/jamanetworkopen.2023.15914.

Reference Type: DERIVED

PMID: 37266943 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1RF1MH114244

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00143675

Identifier Type: -

Identifier Source: org_study_id