Study Stopped
Difficulty recruiting participants and lost personnel.
Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)
Investigating the Use of Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2017
CompletedFirst Posted
Study publicly available on registry
January 23, 2017
CompletedStudy Start
First participant enrolled
August 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2018
CompletedResults Posted
Study results publicly available
May 26, 2020
CompletedMay 26, 2020
May 1, 2020
1.3 years
January 16, 2017
February 24, 2020
May 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 4 weeks
Secondary Outcomes (1)
Change in Motor Cortex Excitability
Baseline, 4 weeks
Study Arms (1)
Transcranial Magnetic Stimulation (TMS)
EXPERIMENTALNon-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
Interventions
Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
Eligibility Criteria
You may qualify if:
- Adults ages 18 and above who are able to consent
- Diagnosis of primary progressive apraxia of speech based on neurological evaluation
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joyce Rios Gomes-Osman
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Joyce R Gomes Osman, PT, PhD
Univeristy of Miami Miller School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 16, 2017
First Posted
January 23, 2017
Study Start
August 9, 2017
Primary Completion
November 13, 2018
Study Completion
November 13, 2018
Last Updated
May 26, 2020
Results First Posted
May 26, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share