Apraxia SpeechNCT03028324
Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)
A study testing Transcranial Magnetic Stimulation (TMS) in people with Apraxia Speech, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apraxia Speech
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2017to 13 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ages 18 and above who are able to consent
- Diagnosis of primary progressive apraxia of speech based on neurological evaluation
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Investigating the Use of Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)
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.
Read the 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
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Medical subject headings
- Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Device
Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period. Receives: Device: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks
Secondary outcomes (1)
Change in Motor Cortex Excitability
Motor cortex excitability will be assessed with single-pulse TMS
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start9 Aug 2017
- Primary completion13 Nov 2018
- Study completion13 Nov 2018
Why it stopped: Difficulty recruiting participants and lost personnel.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Apraxia SpeechStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joyce Rios Gomes Osman, University of Miami
- Investigators
- Joyce R Gomes Osman, PT, PhD, Principal investigator, Univeristy of Miami Miller School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028324
- Sponsor's protocol ID
- 20161125
- Status last verified
- May 2020
- First submitted
- 16 Jan 2017
- Last updated
- 26 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of Transcranial Magnetic Stimulation (TMS) for Primary Progressive Apraxia of Speech (PPAOS)
- ClinicalTrials.gov ID
- NCT03028324
- Acronym / sponsor ID
- 20161125
- Conditions
- Apraxia Speech
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting participants and lost personnel.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 26 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | Device: Transcranial Magnetic Stimulation (TMS)Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ages 18 and above who are able to consent
- Diagnosis of primary progressive apraxia of speech based on neurological evaluation
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period. | Device | Transcranial Magnetic Stimulation (TMS) |
Primary outcome
Change in Speech Performance
Time frame: 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.
1 secondary outcome
Change in Motor Cortex Excitability
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce R Gomes Osman, PT, PhD principal investigator
Univeristy of Miami Miller School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Apraxia Speech, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Speech Performance (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.