Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy

NCT04934371 | Not Yet Recruiting FDA Device

• 1 other identifier: 2105766514
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus, Subjective; Hyperacusis; Hearing Disorders

Outcome Measures

Primary Outcomes (5)

• 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)

  through study completion, an average of 1 year

• 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)

  through study completion, an average of 1 year

• 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)

  through study completion, an average of 1 year

• mean change on the Tinnitus Primary Function Questionnaire (TPFQ)

  change in the tinnitus perception (score: 0-10; higher score indicates more severe tinnitus)

  through study completion, an average of 1 year

• 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

  through study completion, an average of 1 year

Secondary Outcomes (2)

• change in electrophysiological measures

  through study completion, an average of 1 year

• change in functional connectivity measured with fMRI

  through study completion, an average of 1 year

Study Arms (2)

active TDCS and listening therapy

ACTIVE COMPARATOR

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.

Device: Transcranial Direct Current Stimulation (tDCS)

sham TDCS and listening therapy

SHAM COMPARATOR

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

Device: Sham TDCS

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Also known as: NeurConn1 Channel DC-Stimulator Plus (neuroCare Group, München, Germany)

active TDCS and listening therapy

Sham TDCS DEVICE

Sham control will be administered to the same area as active TDCS

Also known as: sham transcranial direct current simulation (tDCS)

sham TDCS and listening therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721-0071, United States

Location

Related Publications (5)

• 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.

  PMID: 20948722 BACKGROUND

• Baguley DM. Hyperacusis. J R Soc Med. 2003 Dec;96(12):582-5. doi: 10.1177/014107680309601203. No abstract available.

  PMID: 14645606 BACKGROUND

• 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.

  PMID: 33332414 BACKGROUND

• 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.

  PMID: 16427357 BACKGROUND

• 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.

  PMID: 25551458 BACKGROUND

MeSH Terms

Conditions

Tinnitus; Hyperacusis; Hearing Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Aneta Kielar, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aneta Kielar, PhD

CONTACT

520-621-5105; akielar@email.arizona.edu

Barbara Cone, PhD

CONTACT

520-626-3710; conewess@email.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: January 15, 2025
• Primary Completion: June 30, 2025
• Study Completion: December 15, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)