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

Not Applicable

Withdrawn

• Conditions: Progressive Supranuclear Palsy; Primary Progressive Non Fluent Aphasia; Primary Progressive Nonfluent Aphasia; Corticobasal Degeneration; Nonfluent Aphasia, Progressive; Behavioral Variant of Frontotemporal Dementia
• Interventions: Device: Halo Neuroscience Neurostimulator

• Registration Number: NCT04883229
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-03-22
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-12
• Study Start: 2022-07-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-19
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

History of:

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tDCS +speech therapy followed by sham tDCS + speech therapy	Halo Neuroscience Neurostimulator	-
sham tDCS +speech therapy followed by tDCS + speech therapy	Halo Neuroscience Neurostimulator	-

Primary Outcome Measures

Name	Time	Method
Change in speech intelligibility	baseline and three months post treatment	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

Name	Time	Method
Feasibility of remote use of device	Immediately after the second block of treatment	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.