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tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study

Primary Purpose

Nonfluent Aphasia, Progressive, Primary Progressive Nonfluent Aphasia, Primary Progressive Non Fluent Aphasia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Halo Neuroscience Neurostimulator
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Nonfluent Aphasia, Progressive focused on measuring Motor Speech Disorders, Dysarthria, Apraxia of Speech

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mini Mental Status Exam score > 10
  • diagnosis of nfvPPA via Gorno-Tempini 2011 criteria, or a diagnosis of FTLD syndrome including progressive supranuclear palsy, corticobasal syndrome or behavioral variant frontotemporal dementia PLUS a motor speech disorder (apraxia of speech and/or dysarthria)
  • able to give consent
  • right-handed
  • native English speaker
  • having a caregiver who is also able to sign and understand the caregiver's consent form.

Exclusion Criteria: History of:

  • stroke
  • TBI
  • brain cancer
  • seizures
  • craniotomy, skull surgery or fracture
  • metallic implant in head
  • pacemaker or cardioverter-defibrillator
  • pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    tDCS +speech therapy followed by sham tDCS + speech therapy

    sham tDCS +speech therapy followed by tDCS + speech therapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in speech intelligibility
    Percent intelligible words, calculated by an SLP scoring each word spoken as intelligible or unintelligible, divided by total number of words spoken, during trained and untrained scripted speech.
    Change in speech intelligibility
    Percent intelligible words, calculated by an SLP scoring each word spoken as intelligible or unintelligible, divided by total number of words spoken, during trained and untrained scripted speech.
    Change in speech intelligibility
    Percent intelligible words, calculated by an SLP scoring each word spoken as intelligible or unintelligible, divided by total number of words spoken, during trained and untrained scripted speech.

    Secondary Outcome Measures

    Feasibility of remote use of device
    Acceptability & ease of use of tDCS device from patient's homes. Measured via surveys designed by the investigators. Scores will range from 0 to 100. Higher scores will indicate better acceptability and ease of use.

    Full Information

    First Posted
    March 22, 2020
    Last Updated
    August 16, 2022
    Sponsor
    University of California, San Francisco
    Collaborators
    Halo Neuroscience
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04883229
    Brief Title
    tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study
    Official Title
    tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The tDCS device that was going to be used for this study is no longer being made.
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco
    Collaborators
    Halo Neuroscience

    4. Oversight

    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
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators will test the feasibility of using transcranial direct current stimulation (tDCS) and speech therapy to treat participants with motor speech disorders caused by Frontotemporal Lobar Degeneration Pathology including nonfluent variant Primary Progressive Aphasia, Progressive Supranuclear Palsy, Corticobasal Syndrome, or behavioral variant Frontotemporal Dementia. The investigators will deliver transcranial direct current stimulation (tDCS) either in a clinic setting at the University of California San Francisco, or in patients' homes, via a consumer tDCS device and videoconferencing. Transcranial direct current stimulation (tDCS) is a neuromodulation technique that can enhance the benefits of speech therapy treatment. Participants will receive a dose of tDCS stimulation + speech therapy and a dose of sham tDCS + speech therapy in a randomized double blind crossover study performed either in the clinic or at home via videoconferencing. This study can be performed entirely remotely.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nonfluent Aphasia, Progressive, Primary Progressive Nonfluent Aphasia, Primary Progressive Non Fluent Aphasia, Progressive Supranuclear Palsy, Corticobasal Degeneration, Behavioral Variant of Frontotemporal Dementia
    Keywords
    Motor Speech Disorders, Dysarthria, Apraxia of Speech

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    tDCS +speech therapy followed by sham tDCS + speech therapy
    Arm Type
    Experimental
    Arm Title
    sham tDCS +speech therapy followed by tDCS + speech therapy
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Halo Neuroscience Neurostimulator
    Other Intervention Name(s)
    Speech therapy
    Intervention Description
    Experimental: Neurostimulation of 2 milliamps anodal (active) tDCS stimulation for 20 mins during 1 hour speech therapy sessions, 3 times a week for 8 weeks, plus daily homework. Then a washout period of no treatment, followed by a 8 weeks of sham tDCS treatment during 1 hour speech therapy sessions, 3 times a week for 8 weeks, plus daily homework. Active comparator: Experimental: Sham tDCS stimulation for 20 mins during 1 hour speech therapy sessions, 3 times a week for 8 weeks, plus daily homework. Then a washout period of no treatment, followed by a 8 weeks of neurostimulation of 2 milliamps anodal (active) sham tDCS treatment during 1 hour speech therapy sessions, 3 times a week for 8 weeks.
    Primary Outcome Measure Information:
    Title
    Change in speech intelligibility
    Description
    Percent intelligible words, calculated by an SLP scoring each word spoken as intelligible or unintelligible, divided by total number of words spoken, during trained and untrained scripted speech.
    Time Frame
    baseline and immediately after the first block of treatment
    Title
    Change in speech intelligibility
    Description
    Percent intelligible words, calculated by an SLP scoring each word spoken as intelligible or unintelligible, divided by total number of words spoken, during trained and untrained scripted speech.
    Time Frame
    baseline and immediately after the second block of treatment
    Title
    Change in speech intelligibility
    Description
    Percent intelligible words, calculated by an SLP scoring each word spoken as intelligible or unintelligible, divided by total number of words spoken, during trained and untrained scripted speech.
    Time Frame
    baseline and three months post treatment
    Secondary Outcome Measure Information:
    Title
    Feasibility of remote use of device
    Description
    Acceptability & ease of use of tDCS device from patient's homes. Measured via surveys designed by the investigators. Scores will range from 0 to 100. Higher scores will indicate better acceptability and ease of use.
    Time Frame
    Immediately after the second block of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mini Mental Status Exam score > 10 diagnosis of nfvPPA via Gorno-Tempini 2011 criteria, or a diagnosis of FTLD syndrome including progressive supranuclear palsy, corticobasal syndrome or behavioral variant frontotemporal dementia PLUS a motor speech disorder (apraxia of speech and/or dysarthria) able to give consent right-handed native English speaker having a caregiver who is also able to sign and understand the caregiver's consent form. Exclusion Criteria: History of: stroke TBI brain cancer seizures craniotomy, skull surgery or fracture metallic implant in head pacemaker or cardioverter-defibrillator pregnancy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Luisa Gorno Tempini, MD PhD
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29718131
    Citation
    Henry ML, Hubbard HI, Grasso SM, Mandelli ML, Wilson SM, Sathishkumar MT, Fridriksson J, Daigle W, Boxer AL, Miller BL, Gorno-Tempini ML. Retraining speech production and fluency in non-fluent/agrammatic primary progressive aphasia. Brain. 2018 Jun 1;141(6):1799-1814. doi: 10.1093/brain/awy101. Erratum In: Brain. 2018 Jul 1;141(7):e57.
    Results Reference
    background
    PubMed Identifier
    26097278
    Citation
    Tsapkini K, Frangakis C, Gomez Y, Davis C, Hillis AE. Augmentation of spelling therapy with transcranial direct current stimulation in primary progressive aphasia: Preliminary results and challenges. Aphasiology. 2014;28(8-9):1112-1130. doi: 10.1080/02687038.2014.930410.
    Results Reference
    background
    PubMed Identifier
    31811834
    Citation
    Cotelli M, Manenti R, Ferrari C, Gobbi E, Macis A, Cappa SF. Effectiveness of language training and non-invasive brain stimulation on oral and written naming performance in Primary Progressive Aphasia: A meta-analysis and systematic review. Neurosci Biobehav Rev. 2020 Jan;108:498-525. doi: 10.1016/j.neubiorev.2019.12.003. Epub 2019 Dec 4.
    Results Reference
    background
    PubMed Identifier
    23800543
    Citation
    Wang J, Wu D, Chen Y, Yuan Y, Zhang M. Effects of transcranial direct current stimulation on language improvement and cortical activation in nonfluent variant primary progressive aphasia. Neurosci Lett. 2013 Aug 9;549:29-33. doi: 10.1016/j.neulet.2013.06.019. Epub 2013 Jun 22.
    Results Reference
    background
    PubMed Identifier
    28225155
    Citation
    Charvet L, Shaw M, Dobbs B, Frontario A, Sherman K, Bikson M, Datta A, Krupp L, Zeinapour E, Kasschau M. Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. Neuromodulation. 2018 Jun;21(4):383-389. doi: 10.1111/ner.12583. Epub 2017 Feb 22.
    Results Reference
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    tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study

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