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

University of California San Francisco (UCSF)

Status: Withdrawn

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

Treatments: Device: Halo Neuroscience Neurostimulator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04883229

18-26098

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

tDCS +speech therapy followed by sham tDCS + speech therapy

Experimental group

Treatment:

Device: Halo Neuroscience Neurostimulator

sham tDCS +speech therapy followed by tDCS + speech therapy

Active Comparator group

Treatment:

Device: Halo Neuroscience Neurostimulator