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Non-invasive Brain Stimulation

Brain Stimulation for Speech Disorders

Phase < 1
Recruiting
Led By John Hart, MD
Research Sponsored by The University of Texas at Dallas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to 85 years of age
A formal diagnosis of primary progressive aphasia (nonfluent/agrammatic, semantic, logopenic variants or mixed) and/or progressive apraxia of speech
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment change from baseline to immediate post, and 8 weeks post treatment completion.
Awards & highlights

Study Summary

This trial is testing whether electrical stimulation of the brain can improve speech and language difficulties in patients with primary progressive aphasia or progressive apraxia of speech.

Who is the study for?
This trial is for adults aged 18-85 with primary progressive aphasia or apraxia of speech, who can consent to participate. It's not suitable for those currently in speech therapy, with implanted devices like pacemakers, skull defects, non-native English speakers, a history of seizures or arrhythmias, or if pregnant.Check my eligibility
What is being tested?
The study tests if transcranial direct current stimulation (tDCS) on the brain area linked to memory can help improve speech and language issues in patients with aphasia and apraxia of speech. Speech/language functions are primarily measured alongside other cognitive abilities and EEG readings.See study design
What are the potential side effects?
Potential side effects from tDCS may include mild discomfort at the stimulation site, itching or tingling during application, headache, fatigue after treatment sessions. Serious side effects are rare but could involve seizure risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I have been diagnosed with a specific type of speech disorder.
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I understand the study and can sign the consent myself, or I have a caregiver who can help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment change from baseline to immediate post, and 8 weeks post treatment completion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment change from baseline to immediate post, and 8 weeks post treatment completion. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Category Fluency
Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised
The Apraxia battery for Adults - 2 (ABA - 2)
+2 more
Secondary outcome measures
The Digit Span Forward & Backward
The Digit Symbol Substitution Test
The Hopkins Verbal Learning Test-Revised
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active tDCS treatmentExperimental Treatment1 Intervention
This pilot study has one treatment arm with open-label treatment and will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial direct current stimulation
2012
Completed Phase 3
~650

Find a Location

Who is running the clinical trial?

The University of Texas at DallasLead Sponsor
58 Previous Clinical Trials
106,260 Total Patients Enrolled
John Hart, MDPrincipal InvestigatorUniversity of Texas at Dallas
2 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

Transcranial direct current stimulation (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05368350 — Phase < 1
Primary Progressive Aphasia Research Study Groups: Active tDCS treatment
Primary Progressive Aphasia Clinical Trial 2023: Transcranial direct current stimulation Highlights & Side Effects. Trial Name: NCT05368350 — Phase < 1
Transcranial direct current stimulation (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05368350 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the anticipated enrollment figure for this clinical trial?

"Affirmative. The clinicaltrials.gov website confirms that this medical research study, which was initially published on the 1st of June 2022 and revised most recently in August 12th 2022, is currently looking for volunteers. 8 participants are needed to be enrolled at one site."

Answered by AI

To whom is access to this experiment available?

"This clinical trial is seeking 8 subjects, aged 18 to 85 years old and presenting with semantic dementia. Prospective participants must have had a formal diagnosis of primary progressive aphasia (nonfluent/agrammatic, semantic, logopenic variants or mixed), as well as the capacity to understand and agree to informed consent. Additionally, medical records will be reviewed by physicians in order to assess if an attendant needs to accompany any participant during this process."

Answered by AI

What is the purpose of this investigation?

"This clinical trial has been designed to assess changes in category fluency from baseline over the course of treatment and post-treatment. Secondary outcomes include evaluation for differences in The Digit Span Forward & Backward (Wechsler, D., 2008), The Rey-Osterrieth Complex Figure Test (Rey, A., 1941) and The Digit Symbol Substitution Test (Wechsler, D., 2008)."

Answered by AI

Is there still an opportunity for individuals to join this research project?

"Absolutely, examinees can find this trial posted on clinicaltrials.gov which confirms it is currently recruiting participants. It was first launched June 1st 2022 and the latest update came in August 12th 2022. The study necessitates 8 volunteers from a single medical centre to partake in it."

Answered by AI

Are there any age restrictions in this investigation that would preclude those younger than 30?

"Conforming to the rules of this clinical trial, applicants must be at least 18 years old and not exceed 85."

Answered by AI

Who else is applying?

What state do they live in?
Utah
How old are they?
18 - 65
What site did they apply to?
The University of Texas at Dallas
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Treating Primary Progressive Aphasia and Apraxia of Speech Using Non-invasive Brain Stimulation
John Hart, Jr. 2022. "Treating Primary Progressive Aphasia and Apraxia of Speech Using Non-invasive Brain Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05368350.
All > Aphasia > Frontotemporal Dementia
~1 spots leftby Jun 2024
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