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Behavioural Intervention
tDCS + Language Therapy for Primary Progressive Aphasia (PPA Trial)
N/A
Recruiting
Led By Aneta Kielar, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with PPA by neurologist or speech-language pathologist
Speech-language deficit arising from PPA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
PPA Trial Summary
This trial will use brain stimulation and behavioral therapy to improve language skills in people with Primary Progressive Aphasia.
Who is the study for?
This trial is for individuals diagnosed with Primary Progressive Aphasia or related conditions, who have normal or corrected-to-normal hearing and vision, and a speech-language deficit due to PPA. They must be native English speakers or equivalent. It's not for those with certain neurological disorders like epilepsy, metallic implants, severe diseases like renal failure, psychiatric issues affecting communication, recent brain surgery, pregnancy, substance abuse problems, or a family history of seizures.Check my eligibility
What is being tested?
The study tests whether combining language therapy with transcranial direct current stimulation (tDCS), which is non-invasive brain stimulation (NBS), can improve language functions in people with PPA. Participants will either receive the real tDCS treatment alongside language therapy or a sham (fake) version of tDCS plus the same therapy.See study design
What are the potential side effects?
Potential side effects from tDCS may include mild tingling on the scalp where electrodes are placed during treatment sessions; itching under electrode sites; headache; fatigue; nausea; and in rare cases mood changes.
PPA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PPA by a specialist.
Select...
I have speech or language problems due to primary progressive aphasia.
Select...
My vision is normal or corrected to normal.
PPA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change from baseline scores on the Arizona Phonological Battery
Mean change from baseline scores on the language probe task before and after each session
Mean change from baseline scores on the naming task
PPA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: active TDCSExperimental Treatment1 Intervention
During intervention excitatory/anodal tDCS will be administered alongside speech-language therapy 5 days a week for 2 weeks. The exact location of the stimulation and electrode configuration will be targeted individually based on the optimal site identified in fMRI. TDCS will be administered with NeurConn1 Channel DC- Stimulator Plus (neuroCare Group, München, Germany) according to established guidelines and procedures. The active tDCS will be delivered for 20 minutes using sponge electrodes with a 30-s ramp-up and ramp-down period
Group II: sham TDCSPlacebo Group1 Intervention
The sham will be administered alongside speech-language therapy 5 days a week for 2 weeks. For sham, stimulation will be ramped up and then down to 0 milliamperes (mA) in the first minute of stimulation. The sham parameters were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade out in the first 30 s of tDCS
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Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,574 Total Patients Enrolled
Aneta Kielar, PhDPrincipal InvestigatorUniversity of Arizona
2 Previous Clinical Trials
60 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You use too much alcohol or drugs.I have been diagnosed with PPA by a specialist.Your close family members have a history of epilepsy or other seizure disorders.I have had seizures in the last year.You have severe fear of small spaces.I have been diagnosed with Multiple Sclerosis.I do not have neurological disorders other than the one being studied.My hearing is good.I have speech or language problems due to primary progressive aphasia.You have a metallic heart pump.This criterion is unclear, and I would need more context to provide an accurate summary. Can you please provide more information or clarify the criterion?I have Parkinson's Disease.You have metal plates or implants in your skull.You have a mental health condition that affects how you communicate.I have severe cognitive issues that prevent me from participating in language therapy.You have been diagnosed with mood, anxiety, psychotic, or substance abuse disorders according to the DSM-IV.You have metal implants or dental work that can be affected by magnets.You have a pacemaker.You are not in good health.You have metal implants or devices that could be affected by a strong magnetic field.I do not have severe illnesses like kidney failure.My vision is normal or corrected to normal.I have skin lesions or damage to my skull.I have had brain surgery before.
Research Study Groups:
This trial has the following groups:- Group 1: active TDCS
- Group 2: sham TDCS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to volunteer for this experiment?
"This clinical trial requires 20 individuals aged 45 to 80 who experience aphasia. To be considered eligible, applicants must also possess adequate hearing and vision as well as have sustained speech-language deficits due to PPA."
Answered by AI
Does this trial accept participants who are senior citizens?
"This clinical trial strictly adheres to the inclusion criteria of 45 years old as the minimum age and 80 years old as the maximum."
Answered by AI
How many persons are enrolled in this research project?
"Yes, the trial is seeking enrolment. It was initially uploaded to clinicaltrials.gov on August 30th 2021 and has since been updated June 29th 2022. The research requires 20 participants from a single medical centre."
Answered by AI
Is enrollment still available for individuals interested in participating in this experiment?
"Based on the information publicly available, this clinical trial is presently enrolling qualified participants. The study was first posted in August 2021 and has been updated as recently as June 2022."
Answered by AI
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