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Difficulty recruiting participants and lost personnel.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Device | Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor Cortex Excitability | Motor cortex excitability will be assessed with single-pulse TMS | Baseline, 4 weeks |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Joyce R Gomes Osman, PT, PhD | Univeristy of Miami Miller School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks |
|
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Rios Gomes-Osman | University of Miami | 305-284-2632 | j.gomes@miami.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2018 | Mar 20, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001072 | Apraxias |
| ID | Term |
|---|---|
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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| Secondary | Change in Motor Cortex Excitability | Motor cortex excitability will be assessed with single-pulse TMS | The change in motor excitability data is not available due to the fact that post intervention data was not collected. | Posted | Baseline, 4 weeks |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |