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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nonfluent Aphasia, Progressive, Primary Progressive Nonfluent Aphasia, Primary Progressive Non Fluent Aphasia, Progressive Supranuclear Palsy, Corticobasal Degeneration, Behavioral Variant of Frontotemporal Dementia

Intervention / Treatment
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* Device: Halo Neuroscience Neurostimulator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS +speech therapy followed by sham tDCS + speech therapy<br> | Device: Halo Neuroscience Neurostimulator<br>* 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.<br>* Other names: Speech therapy;|
| Active Comparator: sham tDCS +speech therapy followed by tDCS + speech therapy<br> | Device: Halo Neuroscience Neurostimulator<br>* 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.<br>* Other names: Speech therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and immediately after the first block of treatment | 
| 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. | baseline and immediately after the second block of treatment | 
| 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. | baseline and three months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately after the second block of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor Speech Disorders, Dysarthria, Apraxia of Speech