Clinical trial NCT03028324: 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
Overall status: TERMINATED
Phase: NA
Conditions: Apraxia Speech
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in Speech Performance
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change in Motor Cortex Excitability
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: Univeristy of Miami Miller School of Medicine
name: Joyce R Gomes Osman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: