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

NCT ID: NCT03028324

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-09
• Study Completion Date: 2018-11-13

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.

Conditions

Apraxia Speech

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Transcranial Magnetic Stimulation (TMS)

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

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation (TMS)

Intervention Type: DEVICE

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

Interventions

Transcranial Magnetic Stimulation (TMS)

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Joyce Rios Gomes Osman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joyce R Gomes Osman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Miami Miller School of Medicine

Locations

University of Miami Miller School of Medicine

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

20161125

Identifier Type: -

Identifier Source: org_study_id