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Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy (TDCS)

Primary Purpose

Tinnitus, Subjective, Hyperacusis, Hearing Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sham TDCS
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic tinnitus and or hyperacusis (> 8 months)
  • adults (18-80 years old)

Exclusion Criteria:

  • implanted metal or devices including cochlear implants,
  • bullet wounds, head/neck tattoo,
  • metal in the eyes,
  • other diagnosed neurological disorders (e.g., stroke, Parkinson's, dementia, brain tumors),
  • head trauma or brain surgery, psychiatric disorders,
  • personal or family history of epilepsy, other seizure disorders
  • Individuals with a history of Meniere's Disease, pulsatile tinnitus, otosclerosis, and
  • chronic headaches.
  • conductive hearing loss, or
  • fluctuating hearing thresholds
  • pure tone averages >70dB HL

Sites / Locations

  • University of Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active TDCS and listening therapy

sham TDCS and listening therapy

Arm Description

TDCS will be administered with NeurConn1 Channel DC-Stimulator Plus (neuroCare Group, München, Germany) according to established guidelines and procedures. The active tDCS will be delivered for 20 minutes at 2mA with a 15-s ramp-up and ramp-down period. Excitatory/anodal tDCS or sham will be administered alongside active listening therapy 5 times a week for 2 weeks.

The sham stimulation will also last for 20 min with 15 sec ramp-up and ramp-down, except the current will be turned down gradually to 0 milliamperes (mA) after 30 seconds. The sham procedure provides the same tingling and itching sensation felt during active tDCS. The sham parameters were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade out in the first 30 s of tDCS

Outcomes

Primary Outcome Measures

Mean change in tinnitus severity and annoyance on the tinnitus hearing survey (THS)
change in participants' perception of tinnitus severity on a 0-4 numeric scale compared pre vs. post intervention (Max = 4; higher score indicates more severe tinnitus)
Mean change in the Sound Tolerance Questionnaire ratings
change in the hyper-sensitivity to sound on a scale 0-10 (Max =10, higher score indicates greater sensitivity)
mean change on the Tinnitus Functional Index (TFI) scores
change in the tinnitus perception on a scale 0-10 (Max = 10: higher score indicates greater impairment)
mean change on the Tinnitus Primary Function Questionnaire (TPFQ)
change in the tinnitus perception (score: 0-10; higher score indicates more severe tinnitus)
Mean change in tinnitus and hyperacusis ratings on the Visual Analog Scale
participants' rating on the Visual Analog Scale pre vs. post treatment (0-10), higher scores indicate greater impairment

Secondary Outcome Measures

change in electrophysiological measures
change in mean latency and amplitude of the ERP responses (lower amplitude and increased latency indicate worse performance)
change in functional connectivity measured with fMRI
changes in functional connectivity from pre to post intervention (increase or decrease possible)

Full Information

First Posted
June 14, 2021
Last Updated
September 6, 2023
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT04934371
Brief Title
Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy
Acronym
TDCS
Official Title
Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy: A Double-blind, Sham-controlled, Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to use non-invasive transcranial direct current stimulation (tDCS) combined with active listening therapy to treat tinnitus and hyperacusis and related conditions.
Detailed Description
Tinnitus is characterized by the subjective perception of sound in the ears or in the brain without external stimulus. In about 30-50% of patients, tinnitus co-occurs with hyperacusis, which is abnormal sensitivity to sounds even at low levels. Chronic tinnitus and hyperacusis can be devastating since a significant proportion of sufferers develop sleep disturbances, psychiatric conditions, and a small fraction commit suicide. Tinnitus is often accompanied by difficulty concentrating and impairment on tasks that require sustained attention and executive control. Currently there is no satisfactory treatment for tinnitus and hyperacusis, contributing to patients' distress. Thus, there is an urgent need for interventions that would suppress the symptoms and possibly cure the disorder. Although, the pathophysiology of tinnitus and hyperacusis is not well understood, neurobiological research suggests that tinnitus and hyperacusis can be attributed to maladaptive neuroplasticity triggered by damage in the auditory system. Most symptoms of tinnitus have been attributed to the hyperactivity and reorganization in the auditory cortex (AC) and dorsolateral prefrontal brain regions (DLPFC). This suggests that electrical stimulation to the abnormally activated regions might modulate these overactive regions and reduce tinnitus and hyperacusis. TDCS is a noninvasive neurostimulation technique that uses weak electric currents (1-2 mA) applied to the scalp to modulate brain responsiveness by temporarily altering neuronal resting membrane potentials. It is proposed that this approach has a potential therapeutic value in treating tinnitus and hyperacusis. Our proposed project examines whether application of tDCS to AC and DLPFC combined with active listening therapy serves to promote adaptive neuroplasticity and reduce subjective perception of sound and emotional distress. The Aims are to: (1) Determine whether tDCS can lead to significant improvement in tinnitus and hyperacusis symptoms pre- versus post-stimulation and (2) Examine electrophysiological responses and functional connectivity in the fronto-temporal-parietal network of brain regions in response to tDCS vs. sham. The expected outcomes from this research will provide evidence to support the design and implementation of individualized tDCS protocols to potentiate treatment protocols that address the core deficits in tinnitus and hyperacusis. Our data will contribute to a more detailed understanding of the neurobiology of tinnitus and the mechanisms that contribute to the subjective, emotional and cognitive symptoms. The results of our study have a potential to develop effective treatment for the rehabilitation of tinnitus and contribute to the clinical practice. Summary of study sequence and procedures: Week 1: Baseline screening, hearing assessment, tinnitus assessment (2 hours), one magnetic resonance imaging (MRI) scan (45minutes), one electrophysiology recording (EEG-ERP)( 1 hour) Weeks 2-4: tDCS with active listening therapy Part 1 2 weeks of 1-hour sessions using non-invasive brain stimulation paired with active listening therapy Weeks 5 and 6: rest-period, post-treatment assessment, one MRI scan (45 min), one EEG-ERP session (1hour) Weeks 7 to 9: tDCS with active listening therapy Part 2 (1 hour each sessions) 2 weeks of 1-hour sessions using non-invasive brain stimulation paired with active listening therapy Weeks 10 and 12: rest period and post-treatment assessment one MRI scan (45 min), one EEG-ERP session (1hour) Week 18: 2-month follow-up, tinnitus assessment, one MRI scan (45 min), one EEG-ERP session (1 hour)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective, Hyperacusis, Hearing Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each patient will undergo tDCS and active listening therapy. This will be double-blinded randomized-sham controlled intervention during which excitatory/anodal tDCS or sham will be administered alongside active listening therapy 5 times a week for 2 weeks. After 2-month follow up participants will be crossed-over to the other treatment type. (Model AB- BA
Masking
ParticipantCare ProviderInvestigator
Masking Description
All audiological evaluations and tinnitus questionnaires performed before and after treatment will be carried out by trained personnel blind to the treatment condition. The neuroConn DC stimulator has a "study mode" where input codes will be used (the researcher and the participants will be blinded to these codes) and the settings generated will be either a sham or actual stimulation
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active TDCS and listening therapy
Arm Type
Active Comparator
Arm Description
TDCS will be administered with NeurConn1 Channel DC-Stimulator Plus (neuroCare Group, München, Germany) according to established guidelines and procedures. The active tDCS will be delivered for 20 minutes at 2mA with a 15-s ramp-up and ramp-down period. Excitatory/anodal tDCS or sham will be administered alongside active listening therapy 5 times a week for 2 weeks.
Arm Title
sham TDCS and listening therapy
Arm Type
Sham Comparator
Arm Description
The sham stimulation will also last for 20 min with 15 sec ramp-up and ramp-down, except the current will be turned down gradually to 0 milliamperes (mA) after 30 seconds. The sham procedure provides the same tingling and itching sensation felt during active tDCS. The sham parameters were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade out in the first 30 s of tDCS
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
NeurConn1 Channel DC-Stimulator Plus (neuroCare Group, München, Germany)
Intervention Description
TDCS is a procedure that sends weak electrical currents between points on the scalp. Some of this current flows through the brain, and may induce temporary changes in brain activity lasting 30-60 minutes beyond the time of stimulation. TDCS is believed to be very low risk. TDCS has been applied in more than 4900 studies and hundreds of people to treat various neurological and psychiatric conditions, including depression, epilepsy, chronic pain and Parkinson's. In this study we will use tDCS to suppress symptom of tinnitus and hyperacusis.
Intervention Type
Device
Intervention Name(s)
Sham TDCS
Other Intervention Name(s)
sham transcranial direct current simulation (tDCS)
Intervention Description
Sham control will be administered to the same area as active TDCS
Primary Outcome Measure Information:
Title
Mean change in tinnitus severity and annoyance on the tinnitus hearing survey (THS)
Description
change in participants' perception of tinnitus severity on a 0-4 numeric scale compared pre vs. post intervention (Max = 4; higher score indicates more severe tinnitus)
Time Frame
through study completion, an average of 1 year
Title
Mean change in the Sound Tolerance Questionnaire ratings
Description
change in the hyper-sensitivity to sound on a scale 0-10 (Max =10, higher score indicates greater sensitivity)
Time Frame
through study completion, an average of 1 year
Title
mean change on the Tinnitus Functional Index (TFI) scores
Description
change in the tinnitus perception on a scale 0-10 (Max = 10: higher score indicates greater impairment)
Time Frame
through study completion, an average of 1 year
Title
mean change on the Tinnitus Primary Function Questionnaire (TPFQ)
Description
change in the tinnitus perception (score: 0-10; higher score indicates more severe tinnitus)
Time Frame
through study completion, an average of 1 year
Title
Mean change in tinnitus and hyperacusis ratings on the Visual Analog Scale
Description
participants' rating on the Visual Analog Scale pre vs. post treatment (0-10), higher scores indicate greater impairment
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
change in electrophysiological measures
Description
change in mean latency and amplitude of the ERP responses (lower amplitude and increased latency indicate worse performance)
Time Frame
through study completion, an average of 1 year
Title
change in functional connectivity measured with fMRI
Description
changes in functional connectivity from pre to post intervention (increase or decrease possible)
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic tinnitus and or hyperacusis (> 8 months) adults (18-80 years old) Exclusion Criteria: implanted metal or devices including cochlear implants, bullet wounds, head/neck tattoo, metal in the eyes, other diagnosed neurological disorders (e.g., stroke, Parkinson's, dementia, brain tumors), head trauma or brain surgery, psychiatric disorders, personal or family history of epilepsy, other seizure disorders Individuals with a history of Meniere's Disease, pulsatile tinnitus, otosclerosis, and chronic headaches. conductive hearing loss, or fluctuating hearing thresholds pure tone averages >70dB HL
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aneta Kielar, PhD
Phone
520-621-5105
Email
akielar@email.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Cone, PhD
Phone
520-626-3710
Email
conewess@email.arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aneta Kielar, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721-0071
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aneta Kielar, PhD
Phone
520-621-5105
Email
akielar@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
Barbara Cone, PhD
Phone
520-626-3710
Ext
Kielar
Email
akielar@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
Aneta Kielar, PhD
First Name & Middle Initial & Last Name & Degree
Barbara Cone, PhD
First Name & Middle Initial & Last Name & Degree
David Velenovsky, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20948722
Citation
Arul-Anandam AP, Loo C, Sachdev P. Transcranial direct current stimulation - what is the evidence for its efficacy and safety? F1000 Med Rep. 2009 Jul 27;1:58. doi: 10.3410/M1-58.
Results Reference
background
PubMed Identifier
14645606
Citation
Baguley DM. Hyperacusis. J R Soc Med. 2003 Dec;96(12):582-5. doi: 10.1177/014107680309601203. No abstract available.
Results Reference
background
PubMed Identifier
33332414
Citation
Cardon E, Joossen I, Vermeersch H, Jacquemin L, Mertens G, Vanderveken OM, Topsakal V, Van de Heyning P, Van Rompaey V, Gilles A. Systematic review and meta-analysis of late auditory evoked potentials as a candidate biomarker in the assessment of tinnitus. PLoS One. 2020 Dec 17;15(12):e0243785. doi: 10.1371/journal.pone.0243785. eCollection 2020.
Results Reference
background
PubMed Identifier
16427357
Citation
Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.
Results Reference
background
PubMed Identifier
25551458
Citation
Henry JA, Griest S, Zaugg TL, Thielman E, Kaelin C, Galvez G, Carlson KF. Tinnitus and hearing survey: a screening tool to differentiate bothersome tinnitus from hearing difficulties. Am J Audiol. 2015 Mar;24(1):66-77. doi: 10.1044/2014_AJA-14-0042.
Results Reference
background

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Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy

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