What side effects are associated with this type of intervention?

Transcranial direct current stimulation (tDCS) is generally well-tolerated, but some common side effects include mild skin irritation or redness at the site of electrode placement, tingling sensations, and headaches. Less frequently, users may experience dizziness or nausea. These side effects are typically mild and transient. It is important to discuss any concerns with a healthcare provider before starting treatment.

What prior FDA approvals exist?

There are no FDA-approved treatments specifically for Primary Progressive Aphasia (PPA) that are similar to Transcranial Direct Current Stimulation (tDCS). While tDCS and other non-invasive brain stimulation techniques hold promise for improving language functions in PPA, they are still under investigation and not yet part of standard clinical practice.

What other types of research exist?

Promising alternatives to tDCS for PPA patients include repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Alternating Current Stimulation (tACS). Both techniques have shown potential in modulating brain activity and improving language functions. rTMS, in particular, has been studied extensively for various neurological conditions and may offer benefits for PPA patients. Additionally, ongoing research and clinical trials are exploring the efficacy of these methods, making them viable options for treatment in 2024.

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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

Must not have

Epileptic activity in the past 12 months

Multiple Sclerosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Summary

This trial uses a gentle electrical current applied to the scalp to help patients with Primary Progressive Aphasia improve their language abilities. The treatment stimulates specific brain areas, helping the brain reorganize around damaged regions. This method has shown promise in improving language symptoms in patients with primary progressive aphasia and post-stroke 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PPA by a specialist.

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I have speech or language problems due to primary progressive aphasia.

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My vision is normal or corrected to normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had seizures in the last year.

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I have been diagnosed with Multiple Sclerosis.

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I do not have neurological disorders other than the one being studied.

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I have Parkinson's Disease.

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I have severe cognitive issues that prevent me from participating in language therapy.

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I do not have severe illnesses like kidney failure.

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I have skin lesions or damage to my skull.

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I have had brain surgery before.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Direct Current Stimulation (tDCS) and Transcranial Magnetic Stimulation (TMS) are non-invasive brain stimulation techniques used to treat Primary Progressive Aphasia (PPA). tDCS involves applying a low electrical current to the scalp to modulate neuronal activity, potentially enhancing brain plasticity and language function. TMS uses magnetic fields to stimulate nerve cells in the brain, which can help improve language recovery by targeting specific brain regions involved in speech and language. These treatments are significant for PPA patients as they offer a promising approach to mitigate language decline by promoting brain reorganization and improving communication abilities.