NCT04883229

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2020

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

March 22, 2020

Last Update Submit

August 16, 2022

Conditions

Nonfluent Aphasia, ProgressivePrimary Progressive Nonfluent AphasiaPrimary Progressive Non Fluent AphasiaProgressive Supranuclear PalsyCorticobasal DegenerationBehavioral Variant of Frontotemporal Dementia

Keywords

Motor Speech DisordersDysarthriaApraxia of Speech

Outcome Measures

Primary Outcomes (3)

  • Change in speech intelligibility

    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.

    baseline and immediately after the first block of treatment

  • Change in speech intelligibility

    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.

    baseline and immediately after the second block of treatment

  • Change in speech intelligibility

    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.

    baseline and three months post treatment

Secondary Outcomes (1)

  • Feasibility of remote use of device

    Immediately after the second block of treatment

Study Arms (2)

tDCS +speech therapy followed by sham tDCS + speech therapy

EXPERIMENTAL
Device: Halo Neuroscience Neurostimulator

sham tDCS +speech therapy followed by tDCS + speech therapy

ACTIVE COMPARATOR
Device: Halo Neuroscience Neurostimulator

Interventions

Halo Neuroscience NeurostimulatorDEVICE

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.

Also known as: Speech therapy
sham tDCS +speech therapy followed by tDCS + speech therapytDCS +speech therapy followed by sham tDCS + speech therapy

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 29718131BACKGROUND

  • 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.

    PMID: 26097278BACKGROUND

  • 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.

    PMID: 31811834BACKGROUND

  • 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.

    PMID: 23800543BACKGROUND

  • 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.

    PMID: 28225155BACKGROUND

MeSH Terms

Conditions

Primary Progressive Nonfluent AphasiaSupranuclear Palsy, ProgressiveCorticobasal DegenerationPick Disease of the BrainDysarthriaApraxias

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Aphasia, Primary ProgressiveDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesNeurodegenerative DiseasesAphasiaSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBasal Ganglia DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesParalysisEye DiseasesFrontotemporal DementiaArticulation DisordersPsychomotor Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Maria Luisa Gorno Tempini, MD PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2020

First Posted

May 12, 2021

Study Start

July 1, 2022

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share