Apraxia Speech
Conditions
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.
Interventions
DEVICETranscranial Magnetic Stimulation (TMS)
Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Speech Performance | Baseline, 4 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor Cortex Excitability | Baseline, 4 weeks | Motor cortex excitability will be assessed with single-pulse TMS |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Magnetic Stimulation (TMS) Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
Transcranial Magnetic Stimulation (TMS): Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Transcranial Magnetic Stimulation (TMS) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Change in Speech Performance | -8.75 score on a scale | Standard Deviation 8.06 |
Secondary
Change in Motor Cortex Excitability
Motor cortex excitability will be assessed with single-pulse TMS
Time frame: Baseline, 4 weeks
Population: The change in motor excitability data is not available due to the fact that post intervention data was not collected.