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Clinical Trials/NCT03028324
NCT03028324
Terminated
Not Applicable

Investigating the Use of Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)

University of Miami1 site in 1 country4 target enrollmentAugust 9, 2017
ConditionsApraxia Speech

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Apraxia Speech
Sponsor
University of Miami
Enrollment
4
Locations
1
Primary Endpoint
Change in Speech Performance
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to assess the influence of transcranial magnetic stimulation (TMS) on speech performance in individuals with primary progressive apraxia of speech.

Detailed Description

Apraxia of speech (AOS) is a motor speech disorder affecting the programming of motor speech production. It is characterized by the impaired ability to coordinate the sequential, articulatory movements necessary to produce speech sound. It can result from insult to the brain, such as in stroke, or as the presenting sign/symptom of another neurodegenerative disease. TMS is a neurostimulation technique which has been shown to modulate cortical excitability in a non-invasive manner, and has been associated with positive outcomes in a variety of neurological and psychological disorders.There is evidence to support the role of TMS in individuals with primary progressive aphasias. In addition, there is a a case report suggesting an improvement in speech following TMS in an individual with primary progressive AOS. This study is being undertaken to further examine the role of TMS in primary progressive AOS.

Registry
clinicaltrials.gov
Start Date
August 9, 2017
End Date
November 13, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joyce Rios Gomes Osman

Assistant Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

  • Adults ages 18 and above who are able to consent
  • Diagnosis of primary progressive apraxia of speech based on neurological evaluation

Exclusion Criteria

  • Any uncontrolled medical condition expected to limit life expectancy or interfere with participation in the trial (i.e. unstable cancer, severe depression or anxiety by DSM-IV criteria)
  • Abnormal stress test, as determined by the treating physician (unless cardiology clearance provided)
  • Active substance abuse or alcohol dependence
  • Uncorrected vision or hearing deficits that would preclude administration of the cognitive measures
  • Unwilling or unable to provide written informed consent
  • History of fainting spells of unknown or undetermined etiology that might constitute seizures
  • History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or family history of treatment resistant epilepsy
  • No medication is an absolute exclusion from TMS. Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following:
  • The subject's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS active drugs.
  • The published TMS guidelines review medications to be considered with TMS

Outcomes

Primary Outcomes

Change in Speech Performance

Time Frame: Baseline, 4 weeks

Apraxia of Speech Rating Scale has a total range from 0-64, with lower scores indicating lower impairment and higher scores indicating higher impairment.

Secondary Outcomes

  • Change in Motor Cortex Excitability(Baseline, 4 weeks)

Study Sites (1)

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