NCT05120037

Brief Summary

The purpose of this research is to understand how a neurostimulation technique, transcranial electrical stimulation (tES), affects brain function in adults with chronic subjective tinnitus measured with functional magnetic resonance imaging (fMRI). This study targets a specific kind of tES called transcranial direct current stimulation (tDCS), where a mild, constant current is passed between electrodes placed on the scalp.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

November 12, 2021

Last Update Submit

January 10, 2023

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (1)

  • Changes in brain functional connectivity.

    Functional MRI will measure changes in brain function during tDCS. Specifically, the investigators will measure change in functional connectivity of prefrontal cortex (% change in Fisher's z).

    immediate

Secondary Outcomes (1)

  • Changes in tinnitus symptoms

    1 week, 2 weeks, 1 month

Study Arms (2)

Active

EXPERIMENTAL
Device: Transcranial Direct Current Stimulation

Sham

SHAM COMPARATOR
Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current StimulationDEVICE

Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).

ActiveSham

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages between 18 and 75
  • Race/ethnicity: all races and ethnic groups
  • Sex/Gender: all
  • Capacity to provide informed consent
  • Subjective tinnitus symptoms confirmed by patient self report meeting the following criteria:
  • Present for at least one year prior to start of study
  • Present (can be heard when consciously attended to) \>50% of awake time
  • Intrudes (is heard even when attempting to ignore/mask) \>10% of awake time
  • Has discussed tinnitus symptoms with clinician (i.e., physician, audiologist) to confirm low/no likelihood of physical or neurological origin of tinnitus symptoms (e.g., acoustic neuroma, Meniere's Disease, etc.), confirmed by patient self-report
  • Stable standard or no pharmacological treatment regimen for tinnitus with no change in treatment 6 weeks prior to study start

You may not qualify if:

  • Ages below 18 (neurobiology is quite different in children vs. adults)
  • Ages above 75 (cortical excitability changes with age)
  • Tinnitus symptoms with known medial origin, including:
  • Meniere's disease
  • Pulsatile tinnitus
  • Acoustic neuroma
  • Spontaneous optoacoustic emissions
  • Any other known medical origin
  • Severe mood disorder (major depression or anxiety)
  • Diagnosis of any medical condition potentially affecting brain function, including:
  • neuropsychiatric or mental disorders (bipolar, post-traumatic stress disorder, etc.)
  • severe mood disorders (major depression or anxiety)
  • psychotic states or disorders
  • developmental disorders
  • neurological disorders, including mild cognitive impairment
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Translational Imaging at Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

November 12, 2021

First Posted

November 15, 2021

Study Start

January 1, 2022

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

US(1)