Clinical trial NCT04883229: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Halo Neuroscience
First posted: 2021-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

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.


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.

Primary outcomes:
measure: Change in speech intelligibility
timeFrame: baseline and immediately after the first block of treatment
measure: Change in speech intelligibility
timeFrame: baseline and immediately after the second block of treatment
measure: Change in speech intelligibility
timeFrame: baseline and three months post treatment
Secondary outcomes:
measure: Feasibility of remote use of device
timeFrame: Immediately after the second block of treatment
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Maria Luisa Gorno Tempini, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.