Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2

NCT03530306 | Completed DMC

• 1 other identifier: Neuromoddevices TENT-A2
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

This is a four arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Tinnitus Handicap Inventory (THI)

  Between-arm and within-arm changes in THI after 6 weeks of treatment

Other Outcomes (1)

• Tinnitus Handicap Inventory (THI)

  Between-arm and within-arm changes in THI after 12 weeks of treatment

Study Arms (4)

PS1-PS4

ACTIVE COMPARATOR

Device: PS1-PS4

PS6-PS10

ACTIVE COMPARATOR

Device: PS6-PS10

PS7-PS4

ACTIVE COMPARATOR

Device: PS7-PS4

PS9-PS6

ACTIVE COMPARATOR

Device: PS9-PS6

Interventions

PS1-PS4 DEVICE

Participants in this arm shall be given PS1 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.

PS1-PS4

PS6-PS10 DEVICE

Participants in this arm shall be given PS6 during the first half of treatment and PS10 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.

PS6-PS10

PS7-PS4 DEVICE

Participants in this arm shall be given PS7 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.

PS7-PS4

PS9-PS6 DEVICE

Participants in this arm shall be given PS9 during the first half of treatment and PS6 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.

PS9-PS6

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years of age
• Ability to read and understand English
• Willing and able to provide informed consent
• Willing to commit to the full duration of the study
• Baseline Tinnitus Handicap Inventory (THI) score of \>= 38 points
• Subjective tinnitus of 3 months to 10 years
• Maximum AC pure-tone audiometry hearing loss of 80 dB HL in any test frequency in the set {2,3,4,6,8}kHz or 40 dB HL in the set {250,500,1000}Hz either unilaterally or bilaterally
• Baseline Minimum Masking Level (MML) of 20 to 80 dB HL
• Tonal tinnitus

You may not qualify if:

• Diagnosed with objective tinnitus
• Commenced usage of hearing aid within the last 90 days
• Cases where pulsatility is the dominant feature of tinnitus
• Patients whose tinnitus cannot be masked during Minimum Masking Level (MML) assessment
• Meniere's disease
• Significantly severe Loudness Discomfort Level (LDL, less than 30 dB SL)
• Depression or neuro-psychological condition, previously diagnosed or identified from the State-Trait Anxiety Inventory (STAI) with score greater than 120
• Diagnosed with somatic tinnitus resulting from head or neck injury
• Temporomandibular Joint Disorder (TMJ)
• Current or previous involvement in medico-legal cases
• Pregnancy
• Oral piercings
• Neurological condition that may lead to loss of consciousness (e.g. epilepsy) or is considered to be the dominant feature of the tinnitus, as assessed by audiologist or ENT consultant
• Severe cognitive impairment based on Mini Mental State Examination (MMSE, less than 20)
• Patient with a pacemaker or other electro-active implanted device

Sponsors & Collaborators

• Neuromod Devices Ltd.: lead

Study Sites (1)

St. James's Wellness Trust Clinical Research Facility

Dublin, Ireland

Location

Related Publications (2)

• Conlon B, Hamilton C, Hughes S, Meade E, Hall DA, Vanneste S, Langguth B, Lim HH. Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters. JMIR Res Protoc. 2019 Sep 27;8(9):e13176. doi: 10.2196/13176.

  PMID: 31573942 BACKGROUND

• Conlon B, Hamilton C, Meade E, Leong SL, O Connor C, Langguth B, Vanneste S, Hall DA, Hughes S, Lim HH. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Sci Rep. 2022 Jun 30;12(1):10845. doi: 10.1038/s41598-022-13875-x.

  PMID: 35773272 RESULT

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Mr. Brendan Conlon

  St. James's Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: March 20, 2018
• Primary Completion: October 2, 2018
• Study Completion: July 18, 2019
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

IE (1)