Healthy AdultsNCT06861517
EEG-based Brain-computer Interface Database for Motor Rehabilitation
An observational study of Healthy Adults, run by Jaime Alejandro Quiroga Forero at 1 site in Argentina.
Trial summary
The human brain, as a processing center, controls bodily, cognitive, emotional and social functions, enabling perception, signal analysis and decision making. However, these functions can be affected by acquired brain injury (ABI), resulting from traumatic (blows to the head) or non-traumatic factors (tumors, strokes… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- 2 Sep 2024to 1 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Volunteers of legal age and under 60 years of age, of any gender and without a history of neurological diseases
Who may be able to join
- Willingness and ability to fully understand the purpose and scope of the experiment and to comply with the experiment instructions.
- Ability to easily distinguish visually the figures in the study.
- Ability to perform tasks that demand sustained concentration.
Who cannot join
- History of neurological diseases.
- Suffering from any type of musculoskeletal disorder that limits the motor skills necessary for the experiment.
- Having a significant hearing loss that prevents him/her from hearing the study instructions.
- Pregnancy.
- Lack of cooperation.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Faculty of Engineering, National University of Entre Ríos
Oro Verde, Entre Ríos Province, 3100
About this study
Official title: Deep Dictionaries for Feature Extraction in Context of Sparse Data for Electroencephalographic Signals from Brain-computer Interfaces
The human brain, as a processing center, controls bodily, cognitive, emotional and social functions, enabling perception, signal analysis and decision making. However, these functions can be affected by acquired brain injury (ABI), resulting from traumatic (blows to the head) or non-traumatic factors (tumors, strokes, infections, among others). Annually, about 55 million new cases of ABI are reported, with sequelae that can affect the quality of life of patients and their families. This scenario has driven research into tools to mitigate and recover lost capabilities. The Center for Rehabilitation Engineering and Neuromuscular and Sensory Research (CIRINS) of the Faculty of Engineering of the National University of Entre Ríos in Argentina has developed neuromuscular and sensory rehabilitation systems, with a focus on the innovation of motor rehabilitation tools using EEG-based brain-computer interfaces (BCI). These BCIs stand out for their economy and versatility, showing significant effects in the rehabilitation of motor functions. Challenges in BCI include signal complexity, artifacts, and inter-person variability, making it difficult to estimate user intent and extending calibration time. To mitigate these problems, strategies based on Deep Learning and dictionary learning have been proposed, which allow for sparse representations of data, being robust to noise and missing data, but with challenges in classification. The study proposes to develop a database of electroencephalographic signals applicable in the development of new algorithms for processing and feature extraction of this type of signals, contributing to the development of technology that supports rehabilitation processes.
- Conditions
- Healthy Adults
- Keywords
- EEG Signals Database, BCI, Effective Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthly Volunteer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory motor rhythms power bands
The volunteer performs a movement task after a cue. A 32-channel EEG records signals following the 10-20 system and measures sensory-motor rhythm power bands.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start2 Sep 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Jaime Alejandro Quiroga Forero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaime Alejandro Quiroga Forero, Universidad Nacional de Entre Rios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861517
- Sponsor's protocol ID
- IS004678
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will focus on electroencephalography signals, therefore for now it is not considered relevant to include data from individual participants (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Dictionaries for Feature Extraction in Context of Sparse Data for Electroencephalographic Signals from Brain-computer Interfaces
- ClinicalTrials.gov ID
- NCT06861517
- Acronym / sponsor ID
- IS004678
- Conditions
- Healthy Adults
- Keywords
- EEG Signals Database, BCI, Effective Motor Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jaime Alejandro Quiroga ForeroUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The human brain, as a processing center, controls bodily, cognitive, emotional and social functions, enabling perception, signal analysis and decision making. However, these functions can be affected by acquired brain injury (ABI), resulting from traumatic (blows to the head) or non-traumatic factors (tumors, strokes, infections, among others). Annually, about 55 million new cases of ABI are reported, with sequelae that can affect the quality of life of patients and their families. This scenario has driven research into tools to mitigate and recover lost capabilities. The Center for Rehabilitation Engineering and Neuromuscular and Sensory Research (CIRINS) of the Faculty of Engineering of the National University of Entre Ríos in Argentina has developed neuromuscular and sensory rehabilitation systems, with a focus on the innovation of motor rehabilitation tools using EEG-based brain-computer interfaces (BCI). These BCIs stand out for their economy and versatility, showing significant effects in the rehabilitation of motor functions. Challenges in BCI include signal complexity, artifacts, and inter-person variability, making it difficult to estimate user intent and extending calibration time. To mitigate these problems, strategies based on Deep Learning and dictionary learning have been proposed, which allow for sparse representations of data, being robust to noise and missing data, but with challenges in classification. The study proposes to develop a database of electroencephalographic signals applicable in the development of new algorithms for processing and feature extraction of this type of signals, contributing to the development of technology that supports rehabilitation processes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthly Volunteer | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteers of legal age and under 60 years of age, of any gender and without a history of neurological diseases
Key inclusion criteria (3 listed)
- Willingness and ability to fully understand the purpose and scope of the experiment and to comply with the experiment instructions.
- Ability to easily distinguish visually the figures in the study.
- Ability to perform tasks that demand sustained concentration.
Key exclusion criteria (5 listed)
- History of neurological diseases.
- Suffering from any type of musculoskeletal disorder that limits the motor skills necessary for the experiment.
- Having a significant hearing loss that prevents him/her from hearing the study instructions.
- Pregnancy.
- Lack of cooperation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory motor rhythms power bands
Time frame: Day 1
The volunteer performs a movement task after a cue. A 32-channel EEG records signals following the 10-20 system and measures sensory-motor rhythm power bands.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Publication about EEG Sensorimotor RhythmsLink provided by the sponsor.
- Motor Intention in EEG-Based BCILink provided by the sponsor.
- Individual participant dataSharing planned: No. The study will focus on electroencephalography signals, therefore for now it is not considered relevant to include data from individual participants (IPD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adults, run by Jaime Alejandro Quiroga Forero at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory motor rhythms power bands (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.