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

May 22, 2020 updated by: Joyce Rios Gomes Osman, University of Miami

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

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Any metal in the brain, skull or elsewhere unless approved by the responsible MD
  • Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
  • Substance abuse or dependence within the past six months
  • Absence of corticospinal functional integrity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Magnetic Stimulation (TMS)
Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Motor Cortex Excitability
Time Frame: Baseline, 4 weeks
Motor cortex excitability will be assessed with single-pulse TMS
Baseline, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joyce R Gomes Osman, PT, PhD, Univeristy of Miami Miller School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2017

Primary Completion (Actual)

November 13, 2018

Study Completion (Actual)

November 13, 2018

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

May 26, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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