~30 spots leftby Oct 2027

HD-tDCS + Language Therapy for Primary Progressive Aphasia

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Kyrana Tsapkini, PhD
Overseen ByKyrana Tsapkini, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Neurological disease, Hearing loss, Visual acuity loss, Advanced dementia, Psychiatric disorders, others
No Placebo Group

Trial Summary

What is the purpose of this trial?

AD afflicts over 5.5. million Americans and is one of the most expensive diseases worldwide. In AD the variant in which language functions are most affected are referred to as 'logopenic variant Primary Progressive Aphasia' (lvPPA). Language deficits dramatically impair communication and quality of life for both patients and caregivers. PPA usually has an early onset (50-65 years of age), detrimentally affecting work and family life. Studies have identified verbal short-term memory/working memory (vSTM/WM) as a primary deficit and cause of language impairment. In the first cycle of this award, the investigators asked the question of whether language therapy effects could be augmented by electrical stimulation. The investigators conducted the largest to-date randomized, double-blind, sham-controlled, crossover, clinical trial to determine the effects of transcranial direct current stimulation (tDCS) in PPA. The investigators found that tDCS over the left inferior frontal gyrus (L_IFG), one of the major language hubs in the brain, significantly enhanced the effects of a written naming and spelling intervention. In addition, findings demonstrated that tDCS modulates functional connectivity between the stimulated area and other networks (e.g. functionally and structurally connected areas), and that tDCS modulates the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). In terms of tDCS, the investigators have been identified several predictors to determine the beneficience of tDCS including (a) PPA variant, (b) initial performance on cognitive/language tasks, particularly vSTM/WM, and (c) initial white-matter integrity and structure. These findings support the notion that tDCS benefits generalize beyond the treatment tasks and has led to the important question of the present study: How can we implement treatments to product benefits that maximally generalize to untrained but vital language/cognitive functions. To address the above question, the investigators will test recent neuroplasticity theories that claim that the benefits of neuromodulation to language-specific areas generalize to other language functions within the language network, while neuromodulation of a domain-general/multiple-demands area generalizes to both domain-general, executive and language functions. The two areas to be stimulated will be the supramarginal gyrus (SMG) and left dorsolateral prefrontal cortex (DLPFC) respectively. The left supramarginal gyrus (L_SMG) in particular, specializes in phonological processing, namely phonological verbal short-term memory (vSTM), i.e., the ability to temporarily store phonological (and graphemic) information in order. The domain of vSTM affects many language tasks (repetition, naming, syntax), which makes it an ideal treatment target and the L_SMG an ideal stimulation target, since generalization of tDCS effects to other language tasks is driven by the function (computation) of the stimulated area. By testing a fundamental principle of neuromodulation in a devastating neurodegenerative disorder, the investigators will significantly advance the field of neurorehabilitation in early-onset dementias. Aim 1: To determine whether vSTM/WM behavioral therapy combined with high definition (HD)-tDCS over the L_SMG will induce more generalization to language-specific tasks than to executive tasks, whereas stimulation over the LDPFC will induce equivalent generalization to both executive and language-specific tasks. Aim 2: To understand the mechanism of tDCS by measuring tDCS-induced changes in network functional connectivity (FC) and GABA in the LSMG and LDPFC. The investigators will carry out resting-state functional magnetic resonance imaging (rsfMRI), (MPRAGE), diffusion-weighted imaging (DWI), perfusion imaging (pCASL), and magnetic resonance spectroscopy (MRS), before, after, and 3-months post-intervention. Aim 3: To identify the neural, cognitive, physiological, clinical and demographic characteristics (biomarkers) that predict sham, tDCS, and tDCS vs. sham effects on vSTM and related language tasks in PPA. The investigators will evaluate neural (functional and structural connectivity, cortical volume, neuropeptides, and perfusion), cognitive (memory, attention, executive) and language functions, clinical (severity), physiological (sleep), and demographic (age, gender) characteristics, and the investigators will analyze the effects on vSTM and other language/cognitive outcomes immediately after intervention and at 3 months post-intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment HD-tDCS + Language Therapy for Primary Progressive Aphasia?

Research suggests that transcranial direct current stimulation (tDCS), when combined with language therapy, can improve language abilities in people with primary progressive aphasia (PPA). Studies have shown improvements in speech production and grammatical comprehension, indicating that tDCS may help enhance language performance in some individuals with PPA.12345

Is HD-tDCS safe for humans?

Transcranial direct current stimulation (tDCS), including its high-definition version (HD-tDCS), is generally considered safe, portable, and noninvasive for use in humans, as it has been used in various studies to enhance therapy outcomes without significant safety concerns.36789

How does the HD-tDCS treatment for Primary Progressive Aphasia differ from other treatments?

The HD-tDCS treatment is unique because it uses a non-invasive electrical stimulation technique to target specific brain areas involved in language, potentially enhancing the effects of language therapy. Unlike traditional drug treatments, this approach directly stimulates brain activity to improve language function in patients with Primary Progressive Aphasia.23457

Research Team

Kyrana Tsapkini, PhD

Kyrana Tsapkini, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for right-handed individuals aged 50-80 with Primary Progressive Aphasia or dementia, who have completed at least high school and are proficient in English. They must be diagnosed at specialized clinics based on consensus criteria. Healthy controls matched by age and education may also participate.

Inclusion Criteria

I am between 50 and 80 years old.
You use your right hand more often than your left hand.
I have been diagnosed with Primary Progressive Aphasia or dementia.
See 4 more

Exclusion Criteria

People who are left-handed.
Are you right-handed?
Do you have a high-school level education?
See 8 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Sham or active HD-tDCS combined with Language/Cognitive Interventions

3 months
Multiple visits for tDCS sessions and assessments

Washout

A washout period between crossover phases to eliminate carryover effects

3 months

Follow-up

Participants are monitored for changes in language and cognitive functions post-intervention

3 months
Assessments at 1 month and 3 months post-intervention

Treatment Details

Interventions

  • High-definition active tDCS (HD-tDCS) (Device)
  • Sham (Device)
Trial OverviewThe study tests if brain stimulation combined with verbal memory therapy can improve language skills in people with PPA. It compares the effects of stimulating two different brain areas using HD-tDCS during a 'Repeat After Me' treatment versus a sham (placebo-like) procedure.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Sham + Language/Cognitive Intervention(s) firstExperimental Treatment2 Interventions
Participants will receive Sham + Language/Cognitive Intervention(s) first and then receive active HD-tDCS + Language/Cognitive Intervention(s) after a three-month washout period.
Group II: Active HD-tDCS + Language/Cognitive Intervention(s) firstExperimental Treatment2 Interventions
Participants will receive active HD-tDCS + Language/Cognitive Intervention(s) first and then receive Sham + Language/Cognitive Intervention(s) after a three-month washout period.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

Transcranial direct current stimulation (tDCS) applied to 12 patients with semantic variant primary progressive aphasia (sv-PPA) showed significant improvements in semantic accuracy and processing speed, particularly for living categories in verbal tasks.
The study provides evidence for the effectiveness of tDCS in enhancing semantic processing in sv-PPA, supporting the idea of a left temporal-pole network for verbal semantics that can be modulated by targeted brain stimulation.
Direct current stimulation over the anterior temporal areas boosts semantic processing in primary progressive aphasia.Teichmann, M., Lesoil, C., Godard, J., et al.[2022]
In a study involving individuals with Primary Progressive Aphasia (PPA), transcranial direct current stimulation (tDCS) showed potential to improve language abilities, particularly in those with more severe language deficits at baseline.
The study's results suggest that tDCS can enhance global language performance and specific language skills, indicating that the severity of language impairment may help predict which patients will benefit from this treatment.
Baseline Performance Predicts tDCS-Mediated Improvements in Language Symptoms in Primary Progressive Aphasia.McConathey, EM., White, NC., Gervits, F., et al.[2022]
In a study of 39 participants with primary progressive aphasia (PPA), both transcranial direct current stimulation (tDCS) and sham treatment improved language therapy outcomes, with tDCS showing greater benefits, especially for untrained words.
The integrity of white matter pathways in the brain was found to predict the effectiveness of tDCS in enhancing language therapy, suggesting that assessing white matter integrity could help identify patients who are more likely to benefit from these treatments.
White Matter Integrity Predicts Electrical Stimulation (tDCS) and Language Therapy Effects in Primary Progressive Aphasia.Zhao, Y., Ficek, B., Webster, K., et al.[2021]

References

Direct current stimulation over the anterior temporal areas boosts semantic processing in primary progressive aphasia. [2022]
Baseline Performance Predicts tDCS-Mediated Improvements in Language Symptoms in Primary Progressive Aphasia. [2022]
White Matter Integrity Predicts Electrical Stimulation (tDCS) and Language Therapy Effects in Primary Progressive Aphasia. [2021]
Transcranial direct current stimulation for the treatment of primary progressive aphasia: An open-label pilot study. [2022]
A Systematic Review of Transcranial Direct Current Stimulation in Primary Progressive Aphasia: Methodological Considerations. [2022]
Effect of Anodal tDCS on Articulatory Accuracy, Word Production, and Syllable Repetition in Subjects with Aphasia: A Crossover, Double-Blinded, Sham-Controlled Trial. [2021]
Transcranial direct current stimulation in post stroke aphasia and primary progressive aphasia: Current knowledge and future clinical applications. [2019]
Transcranial direct current stimulation (tDCS) for improving aphasia after stroke: a systematic review with network meta-analysis of randomized controlled trials. [2020]
Clinical Feasibility of Combining Transcranial Direct Current Stimulation with Standard Aphasia Therapy. [2022]