tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study
NCT04883229 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2022-08-19
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.
Conditions
- Nonfluent Aphasia, Progressive
- Primary Progressive Nonfluent Aphasia
- Primary Progressive Non Fluent Aphasia
- Progressive Supranuclear Palsy
- Corticobasal Degeneration
- Behavioral Variant of Frontotemporal Dementia
Interventions
- DEVICE
-
Halo Neuroscience Neurostimulator
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.
Sponsors & Collaborators
-
Halo Neuroscience
collaborator INDUSTRY -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Maria Luisa Gorno Tempini, MD PhD · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DEVICE_FEASIBILITY
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 95 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-01
- Primary Completion
- 2023-11-30
- Completion
- 2023-11-30
- FDA Device
- Yes
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