- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07554105
Effect of Transcranial Random Noise Stimulation on the Performance in Language Tasks (tRNSlang)
Language is an essential part of daily life, enabling us to communicate, understand others, read, and learn. Certain brain injuries can disrupt these abilities, and current treatments do not always lead to a full recovery. To improve future therapeutic approaches, it is necessary to better understand how the brain processes language and how its activity can be modulated.
This study aims to evaluate the effects of a non-invasive brain stimulation technique called transcranial random noise stimulation. This method involves applying a very weak electrical current to the scalp to modulate the activity of brain regions involved in language. It is commonly used in research and is considered safe when administered in accordance with current guidelines.
Healthy adult volunteers will participate in this study. Each participant will take part in two sessions spaced about a week apart. During one session, active stimulation will be used, and during the other, placebo stimulation will be used. Placebo stimulation resembles the actual stimulation but has no active effect. Neither the participants nor the researchers will know which type of stimulation is being used during each session.
During the sessions, participants will perform various language tasks, and their brain activity will be recorded using an electroencephalogram (EEG), a painless method.
This study does not provide any direct benefit to participants. The risks are low and limited to temporary sensations, such as a tingling sensation on the scalp. The results will provide a better understanding of how the brain processes language and could eventually contribute to the development of new rehabilitation approaches.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adrian Guggisberg, MD
- Phone Number: +41223723700
- Email: adrian.guggisberg@hug.ch
Study Locations
-
-
Canton of Geneva
-
Geneva, Canton of Geneva, Switzerland, 1211
- Recruiting
- Division of Neurorehabilitation, University Hospital of Geneva
-
Principal Investigator:
- Adrian G Guggisberg, MD
-
Contact:
- Adrian G Guggisberg, MD
- Phone Number: +41223723700
- Email: adrian.guggisberg@hcuge.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: 18-35 years or 60-90 years
- Native French speakers
- Right handed
- Willing and able to provide informed consent
- Normal or corrected-to-normal vision and hearing
Exclusion Criteria:
- History of neurological or psychiatric disease
- Regular consumption of benzodiazepines, neuroleptics, or psychoactive drugs
- Major language deficit, developmental language disorder, arthropathies and other mechanical language impairments
- Inability to understand or follow study procedures
Contraindications to brain stimulation, such as
- History of epilepsy or severe migraine
- Pacemaker or other active implants
- Metallic objects in the head
- Skull breach such as craniotomy
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Younger adults
age 15-35 years
|
active HD-tRNS
current will be ramped up for 30 seconds and then switched of, to mimic the subjective sensation of tRNS.
|
|
Other: Elderly adults
age 60-90 years
|
active HD-tRNS
current will be ramped up for 30 seconds and then switched of, to mimic the subjective sensation of tRNS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite score
Time Frame: Periprocedural
|
composite behavioural score reflecting overall language performance across four language domains (phonological, semantic, morphosyntactic, and reading)
|
Periprocedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phonological processing
Time Frame: Periprocedural
|
pseudoword reading task: accuracy (% correct) and response latency (ms)
|
Periprocedural
|
|
Semantic processing
Time Frame: Periprocedural
|
semantic fluency task: number of correct words produced within 1 min
|
Periprocedural
|
|
Morphosyntactic processing
Time Frame: Periprocedural
|
grammaticality judgment task: accuracy (% correct) and response latency (ms)
|
Periprocedural
|
|
Reading speed
Time Frame: Periprocedural
|
International reading speed test IReST: Reading time (s), words per minute, and error count
|
Periprocedural
|
|
Sustained attention
Time Frame: Periprocedural
|
d2-R: standard concentration performance score and error rate (control measure)
|
Periprocedural
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-D0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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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