- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07546292
Enhancing Letter-Speech Sound Learning and Reading Network Activation With Transcranial Electrical Stimulation (LexiStim)
Transcranial Electrical Stimulation and the Reading Brain: Toward Novel Interventions for Reading Impairments
Study Overview
Status
Intervention / Treatment
Detailed Description
This study investigates the effects of transcranial electrical stimulation (tES) on the brain and its potential to enhance reading-related learning. The aim is to identify novel techniques for treating developmental dyslexia, which is a common learning disorder that occurs in childhood and can persist into adulthood. Typically, standard therapy for dyslexia consists of specific reading exercises; however, such training often does not fully remediate the difficulties.
This study, therefore, evaluates how transcranial electrical stimulation may be applied to support learning and ultimately reading. During the stimulation, participants perform an artificial orthography learning task simulating letter-speech sound learning. Whereas previous tES reading studies have focused primarily on behavioral outcomes, the present study additionally measures brain activity using fMRI to elucidate how tES affects neural processing and how these effects may relate to reading abilities.
The knowledge gained from this project is intended to support the future development of transcranial electrical stimulation as an intervention for adults and children with developmental dyslexia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Silvia Brem, Prof. Dr.
- Phone Number: +41 (0)58 384 67 11
- Email: silvia.brem@kjpd.uzh.ch
Study Locations
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Zurich, Switzerland
- Recruiting
- University Hospital of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-35
- All genders
- Written informed consent by the participant
- German speaking (native)
- Right-handed
Exclusion Criteria:
- Diagnoses of neurological disorders, intellectual disabilities, or psychiatric disorders (We do not exclude participants with common comorbidities of dyslexia, specifically dyscalculia, Attention Deficit/Hyperactivity Disorder, or Autism Spectrum Disorders)
- History of any acquired brain damage or evidence of fetal alcohol syndrome
- Hearing problems and vision problems that cannot be corrected
- Inability to follow procedures or understand the instructions given in (Swiss-)German
- Current use of psychoactive medications or substances, or a history of substance abuse that may affect brain function, performance or MRI signal quality
- A nonverbal IQ < 80
- Having previously participated in a transcranial electrical stimulation study
- Knowledge to read or write in a language using foreign letters (i.e., different from the Latin alphabet)
- Contraindications to brain stimulation or MRI, such as: History of epilepsy or severe migraine; Skull breach such as craniotomy; Wearing neurostimulators or cardiac pacemakers; Wearing hearing aid devices or cochlear implants, which are not MR safe; Having metal pieces in their body (e.g., piercings that cannot be removed and contain metal, screws or plates from surgical operations, wounds from metal splinters or similar); Claustrophobia or problems lying in the scanner (e.g., pain, anxiety); Previous surgery on the head or heart; Being pregnant (a pregnancy test will be conducted at the MR center before the measurement if a female participant suspects she might be pregnant or is uncertain about her pregnancy status according to the Swiss Ethics Leitlinie:
https://swissethics.ch/assets/pos_papiere_leitfaden/20110906_kek_mri.pdf); Having problems lying still (strong cold, tremor, etc.); Wearing non-removable dental braces
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Real Stimulation
Participants will receive transcranial random noise stimulation (tRNS) applied to the left superior temporal gyrus.
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Participants will receive high-frequency tRNS (max.
1.5 mA) applied to the left superior temporal gyrus.
A high-definition setup (3x1 electrodes) will be used to achieve more focal stimulation.
Stimulation will be applied during an artificial orthography learning task with simultaneous fMRI acquisition.
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Sham Comparator: Sham Stimulation
Participants in this group will serve as the control condition.
The setup will be identical to the active stimulation group, but stimulation will be sham, such that no electrical current will be applied for the duration of the session.
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Participants will also have electrodes placed on their scalp.
The setup is programmed to induce a short ramp-up of the chosen electrical current followed by a ramp-down at the beginning and at the end of the stimulation.
In between, no current will be applied.
Sham stimulation will be applied during an artificial orthography learning task with simultaneous fMRI acquisition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Performance in the artificial orthography learning task
Time Frame: At second session, up to 8 weeks after baseline
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Performance on the artificial orthography learning task and the artificial orthography reading fluency test will be compared between the stimulation and sham groups.
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At second session, up to 8 weeks after baseline
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fMRI activation and connectivity during print processing
Time Frame: At baseline (Session 1) and at second session, up to 8 weeks after baseline
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fMRI activation and connectivity of the posterior superior temporal gyrus and other regions of the reading and audiovisual learning networks will be compared before, during and after transcranial electrical stimulation (tES).
The fMRI tasks performed in the second session include artificial orthography learning and explicit print processing (lexical decision task), whereas implicit print processing (one-back task) is performed both at baseline and in the second session.
These changes in activation and connectivity will be compared between the stimulation group and the sham group.
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At baseline (Session 1) and at second session, up to 8 weeks after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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fMRI brain activation and connectivity in further fMRI tasks: audiovisual processing and naturalistic movie watching
Time Frame: At baseline (Session 1) and at second session, up to 8 weeks after baseline
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Brain activation and connectivity during further fMRI tasks, namely an audiovisual localizer task and a movie-watching paradigm, will be investigated and compared between the two groups.
The audiovisual localizer task focuses on brain activation in reading and audiovisual processing regions, and the movie-watching paradigm on connectivity within the resting-state networks.
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At baseline (Session 1) and at second session, up to 8 weeks after baseline
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Reading and reading-related behavioral measures
Time Frame: At baseline (Session 1) and at second session, up to 8 weeks after baseline
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Reading and reading-related tasks, such as word and pseudoword reading, will be performed before and after tES to provide a behavioral estimate of reading skills.
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At baseline (Session 1) and at second session, up to 8 weeks after baseline
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Performance in further cognitive tasks
Time Frame: At baseline (Session 1) and at second session, up to 8 weeks after baseline
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The performance in further cognitive tasks (working memory, attention, rapid automatized naming) will be compared before and after tES.
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At baseline (Session 1) and at second session, up to 8 weeks after baseline
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Specific Learning Disorder
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Communication Disorders
- Language Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Learning Disabilities
- Dyslexia
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- BASEC2025-01540
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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