Primary Progressive AphasiaNCT03728582
Rehabilitating and Decelerating Language Loss in Primary Progressive Aphasia With tDCS Plus Language Therapy
A study testing Active tDCS plus Speech-Language Therapy in people with Primary Progressive Aphasia and PPA, run by Johns Hopkins University at 1 site in United States.
Trial summary
People with Primary Progressive Aphasia (PPA) are is a debilitating disorder characterized by the gradual loss of language functioning, even though cognitive functioning is relatively well preserved until the advanced stages of the disease. There are very few evidence-based treatment options available. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Primary Progressive Aphasia, PPA
- What is being tested?
- Active tDCS plus Speech-Language Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 30 Mar 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PPA, based on the PPA criteria and presence of naming deficits
- Capable of giving informed consent or indicating another to provide informed consent
- 18 years of age to 100 years of age..
Who cannot join
- Did not speak English before the age of five
- Less than 10 years of education
- Severe naming deficits
- Significant history of drug or alcohol abuse
- History of psychiatric or neurological problems affecting the brain (besides PPA)
- Has experienced seizures during the previous 12 months
Show all 10Show fewer
- History of brain surgery or any metal in the head
- Uncorrected visual loss or hearing loss by self-report
- Use of medications that lower the seizure threshold (e.g., methylphenidate) or use of N-Methyl-D-aspartate (NMDA) receptor antagonists (e.g., memantine)
- Scalp sensitivity (per participant report)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Rehabilitating and Decelerating Language Loss in Primary Progressive Aphasia With Transcranial Direct Current Stimulation (tDCS) Plus Language Therapy
People with Primary Progressive Aphasia (PPA) are is a debilitating disorder characterized by the gradual loss of language functioning, even though cognitive functioning is relatively well preserved until the advanced stages of the disease. There are very few evidence-based treatment options available. This study investigates the behavioral and neural effects of multiple consecutive tDCS sessions paired with language therapy targeting verbs in sentences with individuals with PPA.
Read the detailed description
Primary Progressive Aphasia (PPA) is a debilitating disorder characterized by the gradual loss of language functioning, even though cognitive functioning is relatively well preserved until the advanced stages of the disease. There are three main PPA variants classified based on the pattern of language impairments and areas of atrophy, but anomia is present across all variants in the earliest stages. While there is a significant amount of research investigating multiple treatment approaches for individuals with aphasia resulting from stroke, individuals with PPA have far fewer treatment options to choose from. Recently, a growing body of literature of treatment in stroke-based aphasia have found promising results for pairing traditional language therapy with non-invasive neurostimulation via transcranial direct current stimulation (tDCS). The small amount of studies of the effects of tDCS applied to left inferior frontal gyrus (IFG) in PPA also yield promising results that show tDCS can enhance generalization to untreated structures. Research in stroke-based aphasia has also shown that language outcomes significantly improve when participants are treated with more complex language stimuli, because this treatment approach results in enhanced generalization. For example, therapy that has participants build sentences around verbs has been found to improve word-level verb and noun naming. The current proposal aims to investigate whether combining the benefits of tDCS while providing verb retrieval therapy that uses sentence building to improve word-level retrieval deficits, will enhance word retrieval deficits in PPA and slow the loss of language functioning. It is hypothesized that Furthermore, the proposed study will investigate the atrophy patterns at baseline, to determine which atrophy patterns are predictive of improved word retrieval. Specifically, this proposal aims: 1) to determine whether tDCS to left IFG coupled with therapy promoting verb retrieval within sentences improve noun and verb retrieval in treated and untreated items in individuals with PPA, and 2) To investigate which patterns of atrophy are predictive of maintenance and generalization of word-retrieval in individuals with PPA following tDCS+therapy vs. sham+therapy. This proposed research will allow the investigators to evaluate the potential benefits and sustainability of tDCS in PPA, the generalization of trained items to untrained items, as well as the deceleration of language loss.
- Conditions
- Primary Progressive Aphasia, PPA
- Being tested
- Active tDCS plus Speech-Language Therapy, Sham tDCS plus Speech-Language Therapy
- Keywords
- Aphasia, Language therapy, Neurocognitive Disorders, Frontotemporal Dementia, Dementia, Anomia
- Medical subject headings
- Aphasia, Primary Progressive, Aphasia, Neurocognitive Disorders, Frontotemporal Dementia, Dementia, Anomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS plus Speech-Language TherapyDevice
Also called Active tDCS and speech-therapy
1-2 milliamps (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context.
Sham tDCS plus Speech-Language TherapyDevice
Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS plus Speech-Language Therapy | Experimental | Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be verb naming therapy in a sentence context. This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period. Receives: Device: Active tDCS plus Speech-Language Therapy; Device: Sham tDCS plus Speech-Language Therapy |
| Sham plus Speech-Language Therapy | Sham comparator | Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. Language therapy will be verb naming therapy in a sentence context. This will be followed by active tDCS plus speech-language therapy after a 2 month washout period. Receives: Device: Active tDCS plus Speech-Language Therapy; Device: Sham tDCS plus Speech-Language Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Accuracy of Naming Trained Verbs (0 to 15, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery (OANB)
To determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition). The primary outcome variable will be trained verbs on the Object and Action Naming battery (OANBtrained). The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities. The OANB includes 100 verbs (15 trained, 85 untrained) and 162 nouns.
Measured: Baseline, and 4-7 weeks after treatment begins
Secondary outcomes (5)
Change in Accuracy of Naming Untrained Verbs (0 to 85, Higher Scores Reflect Better Naming Abilities) and Nouns (0 to 162, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
To determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition). The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities. There are 100 verbs (15 trained, 85 untrained) on the OANB, and 162 nouns.
Measured: Baseline, and 4-7 weeks after treatment begins
Change in Accuracy of Naming Trained Verbs (0 to 15, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
To determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition). The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities. There are 100 verbs (15 trained, 85 untrained) and 162 nouns on the OANB.
Measured: Baseline, and 2 months after treatment ends
Change in Accuracy of Naming Untrained Verbs (0 to 85, Higher Scores Reflect Better Naming Abilities) and Untrained Nouns (0 to 162, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
To determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition). The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities. There are 100 verbs (15 trained, 85 untrained) on the OANB, and 162 nouns.
Measured: Baseline, and 2 months after treatment ends
Change in Functional Communication Skills as Assessed by the Functional Assessment of Communication Skills for Adults (ASHA FACS)
The ASHA FACS will be administered pre-treatment and post-treatment to evaluate changes in functional communication skills. The ASHA FACS is used for measuring the functional communication of adults with speech, language, and cognitive communication disorders. The Communicative Independence Scale will be used, which is rated on a 7-point scale ranging from 1 "does not perform the behavior" to 7 "does perform the behavior". The scores on the Communicative Independence Scale range from a low score of 1 to a high score of 7. A higher score on this subscale indicates better ability to communicate independently.
Measured: Baseline, and 4-7 weeks after treatment begins
Change in Functional Communication Skills as Assessed by the Functional Assessment of Communication Skills for Adults (ASHA FACS)
The ASHA FACS will be administered pre- treatment and post treatment to evaluate changes in functional communication skills. The ASHA FACS is used for measuring the functional communication of adults with speech, language, and cognitive communication disorders. The Communicative Independence Scale will be used, which is rated on a 7-point scale ranging from 1 "does not perform the behavior" to 7 "does perform the behavior". The scores on the Communicative Independence Scale range from a low score of 1 to a high score of 7. A higher score on this subscale indicates better ability to communicate independently.
Measured: Baseline, and 2 months after treatment ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start10 Oct 2018
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
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 Primary Progressive AphasiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon M Sheppard, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728582
- Sponsor's protocol ID
- IRB00174879
- Status last verified
- Apr 2023
- First submitted
- 31 Oct 2018
- Last updated
- 27 Apr 2023
- 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 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitating and Decelerating Language Loss in Primary Progressive Aphasia With Transcranial Direct Current Stimulation (tDCS) Plus Language Therapy
- ClinicalTrials.gov ID
- NCT03728582
- Acronym / sponsor ID
- IRB00174879
- Conditions
- Primary Progressive Aphasia, PPA
- Keywords
- Aphasia, Language therapy, Neurocognitive Disorders, Frontotemporal Dementia, Dementia, Anomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Posted 19 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with Primary Progressive Aphasia (PPA) are is a debilitating disorder characterized by the gradual loss of language functioning, even though cognitive functioning is relatively well preserved until the advanced stages of the disease. There are very few evidence-based treatment options available. This study investigates the behavioral and neural effects of multiple consecutive tDCS sessions paired with language therapy targeting verbs in sentences with individuals with PPA.
Detailed description
Primary Progressive Aphasia (PPA) is a debilitating disorder characterized by the gradual loss of language functioning, even though cognitive functioning is relatively well preserved until the advanced stages of the disease. There are three main PPA variants classified based on the pattern of language impairments and areas of atrophy, but anomia is present across all variants in the earliest stages. While there is a significant amount of research investigating multiple treatment approaches for individuals with aphasia resulting from stroke, individuals with PPA have far fewer treatment options to choose from. Recently, a growing body of literature of treatment in stroke-based aphasia have found promising results for pairing traditional language therapy with non-invasive neurostimulation via transcranial direct current stimulation (tDCS). The small amount of studies of the effects of tDCS applied to left inferior frontal gyrus (IFG) in PPA also yield promising results that show tDCS can enhance generalization to untreated structures. Research in stroke-based aphasia has also shown that language outcomes significantly improve when participants are treated with more complex language stimuli, because this treatment approach results in enhanced generalization. For example, therapy that has participants build sentences around verbs has been found to improve word-level verb and noun naming. The current proposal aims to investigate whether combining the benefits of tDCS while providing verb retrieval therapy that uses sentence building to improve word-level retrieval deficits, will enhance word retrieval deficits in PPA and slow the loss of language functioning. It is hypothesized that Furthermore, the proposed study will investigate the atrophy patterns at baseline, to determine which atrophy patterns are predictive of improved word retrieval. Specifically, this proposal aims: 1) to determine whether tDCS to left IFG coupled with therapy promoting verb retrieval within sentences improve noun and verb retrieval in treated and untreated items in individuals with PPA, and 2) To investigate which patterns of atrophy are predictive of maintenance and generalization of word-retrieval in individuals with PPA following tDCS+therapy vs. sham+therapy. This proposed research will allow the investigators to evaluate the potential benefits and sustainability of tDCS in PPA, the generalization of trained items to untrained items, as well as the deceleration of language loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover assignment
| Arm | Type | Receives |
|---|---|---|
| Active tDCS plus Speech-Language Therapy | Experimental | Device: Active tDCS plus Speech-Language Therapy, Device: Sham tDCS plus Speech-Language TherapyActive tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be verb naming therapy in a sentence context. This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period. |
| Sham plus Speech-Language Therapy | Sham comparator | Device: Active tDCS plus Speech-Language Therapy, Device: Sham tDCS plus Speech-Language TherapySham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. Language therapy will be verb naming therapy in a sentence context. This will be followed by active tDCS plus speech-language therapy after a 2 month washout period. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of PPA, based on the PPA criteria and presence of naming deficits
- Capable of giving informed consent or indicating another to provide informed consent
- 18 years of age to 100 years of age..
Key exclusion criteria (10 listed)
- Did not speak English before the age of five
- Less than 10 years of education
- Severe naming deficits
- Significant history of drug or alcohol abuse
- History of psychiatric or neurological problems affecting the brain (besides PPA)
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 |
|---|---|---|
| Active tDCS plus Speech-Language TherapyAlso: Active tDCS and speech-therapy1-2 milliamps (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context. | Device | Active tDCS plus Speech-Language Therapy, Sham plus Speech-Language Therapy |
| Sham tDCS plus Speech-Language TherapySham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context. | Device | Active tDCS plus Speech-Language Therapy, Sham plus Speech-Language Therapy |
Primary outcome
Change in Accuracy of Naming Trained Verbs (0 to 15, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery (OANB)
Time frame: Baseline, and 4-7 weeks after treatment begins
To determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition). The primary outcome variable will be trained verbs on the Object and Action Naming battery (OANBtrained). The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities. The OANB includes 100 verbs (15 trained, 85 untrained) and 162 nouns.
5 secondary outcomes
Change in Accuracy of Naming Untrained Verbs (0 to 85, Higher Scores Reflect Better Naming Abilities) and Nouns (0 to 162, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
Time frame: Baseline, and 4-7 weeks after treatment begins
Change in Accuracy of Naming Trained Verbs (0 to 15, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
Time frame: Baseline, and 2 months after treatment ends
Change in Accuracy of Naming Untrained Verbs (0 to 85, Higher Scores Reflect Better Naming Abilities) and Untrained Nouns (0 to 162, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
Time frame: Baseline, and 2 months after treatment ends
Change in Functional Communication Skills as Assessed by the Functional Assessment of Communication Skills for Adults (ASHA FACS)
Time frame: Baseline, and 4-7 weeks after treatment begins
Change in Functional Communication Skills as Assessed by the Functional Assessment of Communication Skills for Adults (ASHA FACS)
Time frame: Baseline, and 2 months after treatment ends
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- 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.
Shannon M Sheppard, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS plus Speech-Language Therapy in people with Primary Progressive Aphasia and PPA, run by Johns Hopkins University 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 27 Apr 2023. 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. Some participants in this study may receive a placebo. 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 19 Apr 2023). 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 Accuracy of Naming Trained Verbs (0 to 15, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery (OANB) (time frame: Baseline, and 4-7 weeks after treatment begins). 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 27 Apr 2023.