NCT02053961

Brief Summary

The study is a double-blind study designed to evaluate the efficacy of deep transcranial magnetic stimulation (deep TMS) of the left auditory cortex using the HMCIPCC coil, in the treatment of patients with tinnitus

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

January 28, 2014

Last Update Submit

January 24, 2018

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • TQ - Tinnitus questionnaire

    90 days after the last treatment session

Secondary Outcomes (1)

  • VAS (100 - worst possible tinnitus related discomfort; 0 - wellness)

    baseline, week 1: day 1-5, and week 2: day 1-5

Study Arms (2)

1Hz dTMS Real

ACTIVE COMPARATOR

This group will receive dTMS real treatment of 1Hz

Device: Deep Transcranial Magnetic Stimulation

1HZ dTMS SHAM

SHAM COMPARATOR

This group will receive 1HZ dTMS SHAM treatment

Device: Deep Transcranial Magnetic Stimulation

Interventions

Deep Transcranial Magnetic StimulationDEVICE

1Hz dTMS real treatment

1HZ dTMS SHAM1Hz dTMS Real

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged 20-70.
  • Self-report of tinnitus in one or both ears, persisting for over a year, with no other hearing impairment.
  • Mild/moderate/severe tinnitus. Severity of tinnitus will be diagnosed using the TQ (Goebel \& Hiller) / the THI (Newman \& Jacobson).
  • Unresponsive to standard tinnitus medication.
  • Normal results on pure tone audiometry testing (threshold ≤ 25 dB hearing level in all frequencies from 250 to 8000 Hz).
  • Normal middle ear status was demonstrated by tympanometry, stapedius reflex tests, and otoscopy.
  • Normal results on neurological and physiological examinations.
  • Gave their oral and written consent to participate in the trial.

You may not qualify if:

  • A DSM-IV Axis-I psychiatric disorder.
  • Use of medication that may be a risk factor for seizures, such as:
  • antipsychotic medication; high dosage of antidepressant medication; drugs belonging to benzodiazepine class will be permitted if necessary at daily doses up to the equivalent of 2 mg Lorazepam (Lorivan)' any other drug that is considered a risk factor for seizures by the Principal Investigator.
  • History of intolerance to TMS.
  • Diagnosis of a severe personality disorder according to the DSM-IV.
  • Current suicidal ideation.
  • Uncontrolled hypertension.
  • History of epilepsy, seizure, or heat convulsion.
  • History of epilepsy or seizure in first degree relatives.
  • History of head injury or stroke.
  • History of any metallic particles in the head (except dental fillings).
  • History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemakers, cochlear implants, use of neurostimulators, or any medical pumps.
  • History of drug or alcohol abuse.
  • Inability to communicate adequately with examiner.
  • Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Hospital

Holon, Israel

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yair Lampel, Prof.

    Neurology Department, Wolfson Hospital, Israel

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

February 4, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

IL(1)