The overall goal of this study is to assess the detection and discrimination of individual silently or attempted spoken words from the brain area that represents articulation of speech.To address this goal, we defined three primary objectives:1) To…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The three study parameters/endpoints are:
1) decoding (classification accuracy) of silently spoken or attempted words
from the brain area that represents the articulation of speech in both ALS or
PLS patients and healthy controls.
2) The fMRI brain activity pattern related to articulator movements (movement
direction and amplitude);
3) The movement trajectories of the articulators during speech production
4) The fMRI brain activity patterns related to the production of phonemes
5) The fMRI brain activity pattern related to different combinations of
sequences of the same phonemes within a word.
Secondary outcome
The secondary study parameters are the optimal acquisition parameters necessary
to discriminate different words based on fMRI activity from the brain area
representing articulation of speech.
Background summary
People who suffer from neurological disorders that impair their ability to
speak and write, such as amyotrophic lateral sclerosis (ALS) or brainstem
stroke, are left behind in the current age of information and communication. To
bridge this gap, new solutions are devised to retain or restore communication
capabilities. As such, Brain-Computer Interfaces (BCI*s) promise to offer a
completely new avenue towards helping people with motor disabilities to
communicate and interact with their environment. The general goal of BCI
research is to connect the brain directly to a computer, and thereby bypass the
non-functional nerve system. Current strategies have focused on a particular
part of the brain, the hand region of the motor cortex, where attempted hand
movements are accompanied by patterns of neuronal activity that can be detected
and distinguished from each other. However, to restore communication hand
movements might not be the most intuitive approach. Translating silent speech
to a speech computer would be a much more intuitive and effective way of
communication. In this project we investigate whether silently (or attempted)
spoken words can be detected and discriminated from the brain area that
represents articulation of speech: the sensorimotor face area. Prior work has
suggested feasibility of this, but the concrete aim of extracting words for BCI
is yet to be explored. The results of this study will generate important
knowledge for the ultimate goal of enabling people with severe communication
disabilities to communicate in real time by silently articulating words.
Study objective
The overall goal of this study is to assess the detection and discrimination of
individual silently or attempted spoken words from the brain area that
represents articulation of speech.
To address this goal, we defined three primary objectives:
1) To compare the classification results of silently or attempted spoken words
between ALS or PLS patients and healthy controls.
2) to assess the neural representation of articulator movements (movement
direction and amplitude);
3) to assess the influence of the sequence of phonemes within a word in word
classification.
Study design
This is an observational study with invasive techniques (functional magnetic
resonance imaging, fMRI) with a group of individuals with bulbar ALS and a
control group.
Study burden and risks
Although no direct benefits are expected for the subjects of the current study,
the study is expected to increase our understanding of the decodability of
words from the sensorimotor face area, which, in the long run, may provide
people with severe paralysis a method of fast and intuitive communication.
There are no known risks associated with fMRI acquisition. The technique does
not require any contrast agent or ionizing radiation administration. The
Utrecht group has ample experience with fMRI scanning (±400 sessions per year
done on the 7 Tesla MRI scanner). The fMRI procedure is painless; however, some
discomfort may occur due to peripheral nerve stimulation during scanning and
prolonged time lying still with portion of body and head in a confined
tunnel-like device. Additional attention to safety measures will be in place in
the shape of constant communication with a researcher or caregiver throughout
the scanning session. Also, strict inclusion criteria (i.e.: being able to lay
flat during the entirety of one hour of scanning session and being able to use
one of the hands to press the emergency button in the scanner) assures that
included patients have maximum safety and minimum discomfort during the study.
A (para)medic that is familiar with the patient population will be present
during scanning to provide assistance if necessary.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Control group:
- Age 18 or older (between 45 - 75 years for the subgroup of controls that will
be compared to the patient group, see chapter 4.1 )
- Blank neurological history
- Adequate proficiency in Dutch and/or English language
Patient group:
- Age 18 or older
- A diagnosis with bulbar onset ALS or PLS
- A strongly impaired ability to speak
- Ability to lie flat on the scanner bed for the duration of the fMRI scan
(approximately 60 minutes) without respiratory difficulties or significant
saliva build-up
- Ability to press emergency button in the scanner with the hand
- A score of at least 70% on the protocol understanding verification
questionnaire
- Adequate proficiency in Dutch and/or English language
Exclusion criteria
General:
- Noncompliance with MRI safety check list
- Claustrophobia
- Pregnancy
- Inability to hear the instructions presented orally in the scanner
without a hearing aid
Patient group:
- Mechanical ventilation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL73087.041.20 |