An interventional study of Halo Neuroscience Neurostimulator in Nonfluent Aphasia, Progressive, Primary Progressive Nonfluent Aphasia and Primary Progressive Non Fluent Aphasia, sponsored by University of California, San Francisco. Withdrawn. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2022-08-19.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Device feasibility
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.
20 studies on the registry are indexed under Primary Progressive Nonfluent Aphasia; 8 are open to participants now.
Browse Primary Progressive Nonfluent Aphasia studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: History of:
Device: Halo Neuroscience Neurostimulator
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.
Also known as: Speech therapy
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and three months post treatment
Feasibility of remote use of device
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.
Time frame: Immediately after the second block of treatment
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jul 2022; primary completion for Nov 2023, 16 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Primary Progressive Nonfluent Aphasia →
University of California, San Francisco →