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Treating Primary Progressive Aphasia (PPA) Using High-definition tDCS

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ClinicalTrials.gov Identifier: NCT04046991
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
This is a double-blind, sham-controlled, crossover study in which subjects with the non-fluent/agrammatic and logopenic variants of primary progressive aphasia (naPPA and lvPPA, respectively) will undergo language testing and structural and functional brain imaging before and after receiving 10 semi-consecutive daily sessions of real or sham high-definition transcranial direct current stimulation (HD-tDCS) paired with modified constraint-induced language therapy (mCILT). Language testing and brain imaging will be repeated immediately after completion of and 3 months following completion of treatment. The 3-month follow-up will be the primary endpoint. The investigators will examine changes in language performance induced by HD-tDCS + mCILT compared to sham HD-tDCS + mCILT. The investigators will also use network science to analyze brain imaging (fMRI) data to identify network properties associated with baseline PPA severity and tDCS-induced changes in performance. This study will combine knowledge gained from our behavioral, imaging, and network data in order to determine the relative degrees to which these properties predict whether persons with PPA will respond to intervention.

Condition or disease Intervention/treatment Phase
Primary Progressive Aphasia Device: high-definition transcranial direct current stimulation Behavioral: modified constraint-induced language therapy Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Primary Progressive Aphasia (PPA) and Elucidating Neurodegeneration in the Language Network Using Transcranial Direct Current Stimulation (tDCS)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023


Arm Intervention/treatment
Active Comparator: HD-tDCS+mCILT
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of HD-tDCS for 20 minutes using a montage in which a central electrode (1.5mA) is placed over the left frontotemporal area and four surrounding cathodes (.375mA each). Subjects will participate in a modified constraint-induced language therapy.
Device: high-definition transcranial direct current stimulation
High definition transcranial direct current stimulation (HD-tDCS) involves the application of low-intensity current through electrodes placed on the scalp. It is believed to elicit brain effects by producing incremental shifts in the resting membrane potential of large numbers of neurons, which alters neuronal firing rates and thus modulates patterns of brain activity in potentially behaviorally-relevant ways. HD-tDCS differs from conventional transcranial direct current stimulation (tDCS) because it employed smaller electrodes configured in such a way as to deliver more focal stimulation of the brain.

Behavioral: modified constraint-induced language therapy
Modified constraint-induced language therapy (mCILT) is a behavioral language therapy that invokes use-dependent learning in communicative interactions by requiring spoken output and restricting use of alternative forms of communication, such as gestures, as a substitute for spoken output. Other key elements of CILT include massed practice of goal-directed speech and shaping of desired responses by increasing response demands as participants improve. MCILT differs from traditional constraint-induced language therapy (CILT) in three ways: 1) it will be done as an individual therapy with the examiner in the role of a communication partner; 2) treatment will be delivered in short sessions (1 hour rather than a more typical 3-4 hour session); 3) targeting nouns + semantically related verbs to generate noun + verb phrases in treatment, a modification that may be better suited to addressing syntactic structure.

Sham Comparator: Sham+mCILT
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham for 20 minutes using a montage in which a central electrode is placed over the left frontotemporal area and four surrounding cathodes. Subjects will participate in a modified constraint-induced language therapy,
Device: high-definition transcranial direct current stimulation
High definition transcranial direct current stimulation (HD-tDCS) involves the application of low-intensity current through electrodes placed on the scalp. It is believed to elicit brain effects by producing incremental shifts in the resting membrane potential of large numbers of neurons, which alters neuronal firing rates and thus modulates patterns of brain activity in potentially behaviorally-relevant ways. HD-tDCS differs from conventional transcranial direct current stimulation (tDCS) because it employed smaller electrodes configured in such a way as to deliver more focal stimulation of the brain.

Behavioral: modified constraint-induced language therapy
Modified constraint-induced language therapy (mCILT) is a behavioral language therapy that invokes use-dependent learning in communicative interactions by requiring spoken output and restricting use of alternative forms of communication, such as gestures, as a substitute for spoken output. Other key elements of CILT include massed practice of goal-directed speech and shaping of desired responses by increasing response demands as participants improve. MCILT differs from traditional constraint-induced language therapy (CILT) in three ways: 1) it will be done as an individual therapy with the examiner in the role of a communication partner; 2) treatment will be delivered in short sessions (1 hour rather than a more typical 3-4 hour session); 3) targeting nouns + semantically related verbs to generate noun + verb phrases in treatment, a modification that may be better suited to addressing syntactic structure.




Primary Outcome Measures :
  1. Change in Western Aphasia Battery Aphasia Quotient (WAB-AQ) [ Time Frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 14 weeks, 18 weeks, 24 weeks ]
    The primary outcome measure will be the change in score on the WAB-AQ, a score assessing overall aphasia recovery. Scores can range from 0-100. 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. A score of 93 or higher is considered recovered.



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Presence of aphasia attributable to nonfluent agrammatic PPA (naPPA) or logopenic variant PPA (lvPPA)
  2. High school education (or more)
  3. Must be able to understand the nature of the study, and give informed consent
  4. Native English speaker

Exclusion Criteria:

  • Presence of additional neurological illness such as stroke or traumatic brain injury
  • Diagnosis of epilepsy or reoccurening seizures
  • Pacemaker or ICDs
  • Craniotomy or skull breech
  • Small vessel disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046991


Contacts
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Contact: Daniela Sacchetti, MS 215-573-8485 danielas@pennmedicine.upenn.edu
Contact: Olufunsho Faseyitan, MS faseyita@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Daniela Sacchetti, MS         
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04046991     History of Changes
Other Study ID Numbers: TBD - not yet submitted to IRB
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by University of Pennsylvania:
non-invasive brain stimulation
transcranial direct current stimulation (tDCS)
aphasia
Additional relevant MeSH terms:
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Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases