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

Primary Purpose

Apraxia Speech

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Apraxia Speech

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Miller School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Magnetic Stimulation (TMS)

Arm Description

Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.

Outcomes

Primary Outcome Measures

Change in Speech Performance
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 Outcome Measures

Change in Motor Cortex Excitability
Motor cortex excitability will be assessed with single-pulse TMS

Full Information

First Posted
January 16, 2017
Last Updated
May 22, 2020
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03028324
Brief Title
Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)
Official Title
Investigating the Use of Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting participants and lost personnel.
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
November 13, 2018 (Actual)
Study Completion Date
November 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apraxia Speech

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation (TMS)
Arm Type
Experimental
Arm Description
Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Intervention Description
Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
Primary Outcome Measure Information:
Title
Change in Speech Performance
Description
Apraxia of Speech Rating Scale has a total range from 0-64, with lower scores indicating lower impairment and higher scores indicating higher impairment.
Time Frame
Baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Change in Motor Cortex Excitability
Description
Motor cortex excitability will be assessed with single-pulse TMS
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce R Gomes Osman, PT, PhD
Organizational Affiliation
Univeristy of Miami Miller School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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