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

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ClinicalTrials.gov Identifier: NCT04883229
Recruitment Status : Not yet recruiting
First Posted : May 12, 2021
Last Update Posted : May 12, 2021
Sponsor:
Collaborator:
Halo Neuroscience
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Nonfluent Aphasia, Progressive Primary Progressive Nonfluent Aphasia Primary Progressive Non Fluent Aphasia Progressive Supranuclear Palsy Corticobasal Degeneration Behavioral Variant of Frontotemporal Dementia Device: Halo Neuroscience Neurostimulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023


Arm Intervention/treatment
Experimental: tDCS +speech therapy followed by sham tDCS + speech therapy 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.

Other Name: Speech therapy

Active Comparator: sham tDCS +speech therapy followed by tDCS + speech therapy 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.

Other Name: Speech therapy




Primary Outcome Measures :
  1. Change in speech intelligibility [ Time Frame: baseline and immediately after the first block of 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.

  2. Change in speech intelligibility [ Time Frame: baseline and immediately after the second block of 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.

  3. Change in speech intelligibility [ Time Frame: 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 :
  1. Feasibility of remote use of device [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04883229


Contacts
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Contact: Ariane E Welch, MSLP 415 353 9135 ariane.welch@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94158
Contact: Ariane E Welch, MSLP    415-353-9135    ariane.welch@ucsf.edu   
Principal Investigator: Maria Luisa Gorno Tempini, MD PhD         
Sponsors and Collaborators
University of California, San Francisco
Halo Neuroscience
Investigators
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Principal Investigator: Maria Luisa Gorno Tempini, MD PhD University of California, San Francisco
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04883229    
Other Study ID Numbers: 18-26098
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by University of California, San Francisco:
Motor Speech Disorders
Dysarthria
Apraxia of Speech
Additional relevant MeSH terms:
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Aphasia
Supranuclear Palsy, Progressive
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Communication Disorders
Speech Disorders
Aphasia, Broca
Primary Progressive Nonfluent Aphasia
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Language Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Basal Ganglia Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Paralysis
Eye Diseases
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies