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

Apraxia Speech Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03028324
• Other study ID #: 20161125
• Status: Terminated
• Phase: N/A
• Start date: August 9, 2017
• Est. completion date: November 13, 2018

Study information

• Verified date: May 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 13, 2018
• Est. primary completion date: November 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia, Primary Progressive
• Apraxia Speech
• Apraxias
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

Device:
• Transcranial Magnetic Stimulation (TMS)
Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Motor Cortex Excitability	Motor cortex excitability will be assessed with single-pulse TMS	Baseline, 4 weeks