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MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus

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ClinicalTrials.gov Identifier: NCT03544359
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Amber Leaver, Northwestern University

Tracking Information
First Submitted Date  ICMJE May 7, 2018
First Posted Date  ICMJE June 1, 2018
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
Changes in brain function (functional connectivity) [ Time Frame: baseline, interim (1 week after baseline), and post-tES (2 weeks after tES) ]
Changes in temporal coherence (functional connectivity) of local auditory-cortex activity and auditory networks measured with BOLD-fMRI
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
Changes in brain function (functional connectivity) [ Time Frame: baseline, interim (1 week after baseline), and post-treatment (4 weeks after baseline) ]
Changes in temporal coherence (functional connectivity) of local auditory-cortex activity and auditory networks measured with BOLD-fMRI
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
Tinnitus loudness ratings [ Time Frame: daily from date of randomization until 2 weeks after the the last study visit (tES session) ]
Perceived loudness of tinnitus sensation will be measured using a 10-point Likert rating scale, where a rating of "1" indicates no tinnitus and a rating of "10" indicates loudest tinnitus imaginable. In this rating scale, higher ratings indicate more severe symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
Tinnitus loudness ratings [ Time Frame: daily from date of randomization until 30 days after the the last study visit (tES session) ]
Perceived loudness of tinnitus sensation will be measured using a 10-point Likert rating scale, where a rating of "1" indicates no tinnitus and a rating of "10" indicates loudest tinnitus imaginable. In this rating scale, higher ratings indicate more severe symptoms.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus
Official Title  ICMJE Longitudinal Functional MRI Study of Transcranial Electrical Stimulation in Chronic Tinnitus
Brief Summary

The purpose of this research is to understand how a neuromodulation technique, transcranial electrical stimulation (tES), affects brain function in adults with chronic tinnitus measured with functional magnetic resonance imaging (fMRI). We hypothesize that multiple sessions of tES (5 consecutive days) will modulate:

  1. Overall activity and local connectivity within brain regions near tES electrodes, and
  2. Functional connectivity within brain networks associated with brain regions near tES electrodes.

In exploratory analyses, we also measure the extent to which the hypothesized changes listed above a related to changes in tinnitus symptoms after tES.

Detailed Description Chronic subjective tinnitus is a common and sometimes disabling condition, with few effective treatments and no cure. Tinnitus is thought to involve dysfunction in central brain networks subsequent to peripheral injury or interference; thus, neurostimulation therapies that directly target central circuits are receiving growing interest. Of these, noninvasive transcranial electrical stimulation (tES) is an attractive option, due to its relative affordability, mobility, and favorable safety profile. A growing number of studies have demonstrated that tES of temporal/auditory cortex is effective at transiently reducing tinnitus symptoms, including tinnitus loudness and tinnitus distress. However, the results of previous clinical trials are variable, and a mechanistic understanding of tES and its therapeutic effects remains elusive. The main goal of this research is to lay the groundwork for improved, patient-centered approaches to noninvasive neurostimulation therapy for chronic tinnitus. To accomplish this long-term goal, this study will determine how the intrinsic activity and connectivity of auditory networks are affected during simultaneous tES-fMRI of auditory cortex, specifically in those patients who experience reduced tinnitus symptoms after 5 consecutive days of tES. Though the primary goal of the proposed research is to optimize tES for the treatment of tinnitus, these studies will also provide a wealth of information regarding tinnitus pathophysiology and the mechanisms of tES more generally, which is being investigated for the treatment of a wide variety of brain disorders and injuries.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Eligible volunteers will be randomly assigned to receive either 5 consecutive days of active tES or 5 consecutive days of sham/inactive tES.
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Tinnitus, Subjective
Intervention  ICMJE Device: Transcranial electrical stimulation (tES)
In tES, a mild electrical current is passed between two or more electrodes placed on the volunteer's head (scalp). In this study, a mild unvarying (constant) electrical 2mA current is passed between two rubber electrodes placed on the head over auditory cortex for 20 minutes per session for 5 consecutive days. Because the electrical current direction (positive/negative) and current amplitude (2mA) does not vary or change during stimulation, this type of tES is also called transcranial "direct current" stimulation, or tDCS.
Other Name: Transcranial direct current stimulation (tDCS)
Study Arms  ICMJE
  • Active Comparator: Active tES
    Intervention: Device: Transcranial electrical stimulation (tES)
  • Sham Comparator: Sham/Inactive tES
    Intervention: Device: Transcranial electrical stimulation (tES)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2018)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages between 18 and 65
  • Race/ethnicity: all races and ethnic groups
  • Sex/Gender: all
  • Capacity to provide informed consent
  • Subjective tinnitus symptoms for at least one year prior (confirmed by patient self-report)
  • 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 (e.g., SSRI or SNRI) with no change in treatment 6 weeks prior to study start

Exclusion Criteria:

  • Ages below 18 (neurobiology is quite different in children vs. adults)
  • Ages above 65 (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
  • Diagnosis of any medical condition potentially affecting brain function, including: neuropsychiatric or mental disorders, mood disorders (bipolar disorder, anxiety, PTSD), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence, chronic pain (>1 year duration)
  • MRI contraindications: metal or other implants that are not MR-safe, claustrophobia, pregnancy or suspected pregnancy
  • tDCS contraindications*: skin conditions or injuries on the scalp, hair extensions, wigs, braids, etc. that cannot be removed prior to the study, metal implants or pacemakers (also contraindicated for MRI) *Please note that history of seizures or epilepsy, stroke, and brain injury are not safety concerns for tES use, and may be inclusion criteria for other tES studies. However, individuals with history of these conditions will be excluded here because these conditions are not a focus of the current study (see above).
  • Non-English speakers (due to written consent and questionnaires administered)
  • other major medical conditions (e.g., cancer, stroke).
  • Significant history of alcohol/substance abuse or dependence within last 12 months
  • Neurostimulation or neuromodulation treatment for any reason within the past 3 months
  • Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics, or antidepressants.
  • Prisoners will not participate in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amber M Leaver, PhD 3126942966 inmri@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03544359
Other Study ID Numbers  ICMJE STU00207056
R21DC015880 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified research data may be shared upon completion of the study with researchers according to Northwestern IRB approved protocols. Shared data will not include personally identifiable information or protected health information.
Time Frame: After study completion, data will be made available upon request and upon approvals from all relevant regulatory agencies.
Access Criteria: Approval of Institutional Review Board (and/or other relevant regulatory agencies) at all involved institutions.
Responsible Party Amber Leaver, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE Not Provided
PRS Account Northwestern University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP