Experimental device aims to tame disease
NCT ID NCT07688551
First seen Jul 07, 2026 · Last updated Jul 22, 2026 · Updated 6 times
Summary
This trial investigates an unapproved medical device designed to help control a specific disease. Participants receive the device to see if it can reduce symptoms or manage the condition. The study focuses on safety and effectiveness in people with the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- unapproved medical device
- What this could lead to
- If successful, this device could offer a new way to manage the disease and improve quality of life.
- What could go wrong
- The device is not yet approved, and this is an early-stage trial. It may not work as hoped or could have unknown side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Be willing and able to give informed consent. * Be willing and able to comply with study requirements. * Be between 25 and 80 years of age. * Have used English as the primary language for \> 15 years. * Have the diagnosis of aphasia due to a left hemisphere stroke, confirmed by study physician based on past clinical MRI scan or research scan. * Be greater than 6 months post-stroke. * Have Broca's aphasia diagnosed by the WAB-R (fluency score ≤ 5, auditory verbal comprehension score 4-10, repetition score 0-7.9, naming and word finding score \< 9). * Correctly name 140 or fewer items on the PNT. Exclusion Criteria: * History of brain surgery except for during the treatment of the acute stroke. * Seizures during the previous 12-months. * Compromised skin at or near electrode sites (e.g., rash, eczema, wounds, infection). * Correctly name more than 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test). * Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) score of 25 or below. * Participants with open skull defects (e.g., greater than 1 cm) in the area underneath the anode electrode positioning or participants with metal implants or electrical stimulators. * Participants with continuous oxygen therapy which cannot be discontinued for more than 1 hour. * Any condition or situation that the PI determines would significantly interfere with the participant's ability to complete the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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University of South Carolina
RECRUITINGColumbia, South Carolina, 29201, United States
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University of Utah
RECRUITINGSalt Lake City, Utah, 84112, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can hearing your own voice rewire speech after a stroke?
- Zapping the brain to restore speech after stroke?
- Can exercise boost reading recovery in stroke survivors?
- Can training the brain to think about words boost recovery from stroke-related aphasia?
- Can an AI app give a voice to brain tumor patients?
- Brain zaps may unlock lost words after stroke