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Withdrawn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
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
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
NCT ID
NCT04883229
First Posted
March 22, 2020
Last Updated
August 16, 2022
Sponsor
University of California, San Francisco
Collaborators
Halo Neuroscience
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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