The main objective of the proposed study is to investigate the effect of PNS as a means to support the learning process in order to accelerate learning and improve knowledge and competence retention. This will be tested by applying PNS stimulation…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
menselijk presteren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Performance on the learned task, which includes accuracy and reaction times.
Secondary outcome
Performance on sustained attention and cognitive control tasks, sleep scores
and mood scores
Background summary
In a fast-changing world with rapid technological advancements there is a high
pressure on people in the workforce to continually learn and adapt to keep up
with changing demands. A promising method to support the learning process is
peripheral nerve stimulation (PNS). This method involves applying a small
electrical current non-invasively to the cervical branch of the Vagus nerve
(e.g., in the neck) with a medically approved device which is normally used for
treatment of cluster headaches at home. Although studies on the effect of PNS
on learning are scarce, initial results are very promising showing PNS
improving performance on the training task after 2 days, with higher retention
performance at 30 and 60 days post-training. Here we propose to test how PNS
can improve learning on a military-relevant task.
Study objective
The main objective of the proposed study is to investigate the effect of PNS as
a means to support the learning process in order to accelerate learning and
improve knowledge and competence retention. This will be tested by applying PNS
stimulation during training, followed by retention tests at different times
post-training to investigate long-term benefits of stimulation.
Study design
The study design will be a single-blind, sham-controlled, between-subjects
intervention study with two groups of 20 participants. Participants will be
trained on a specialized visual detection task over the course of four days,
spending approximately an hour each day. Participants will receive PNS
stimulation before and after the training task. Retention tests will be
performed 1, 30 and 60 days post-training.
Intervention
Both groups will undergo a 4-day training protocol, with one group receiving
PNS and the second group receiving active sham stimulation. Electrical
stimulation at 25 Hz is applied twice for 2 minutes in the neck using a
handheld device (gammaCore® developed by electroCore®, FDA-approved and
CE-marked to treat cluster headaches and treatment-resistant migraines at
home), before and after each training session.
Study burden and risks
Participants will be invited for a total of 7 sessions of approximately 1-2
hours, 5 of which will be on consecutive days. There are small burden and risks
associated with participation, and there is no risk for any serious (adverse)
event. The burden consists of the following activities:
- Peripheral nerve stimulation: Stimulation will be done with a medically
approved device (for at-home use) that applies a small current to the neck,
targeting a cervical branch of the vagus nerve (i.e., in the neck). Stimulation
will only be applied twice for 2 minutes, once on the left and once on the
right side of the neck, with a 2 minute break in between. Some mild discomfort
may occur locally, which stops when stimulation is stopped. Single session
stimulation is associated with minimal side-effects, and use of the device is
considered safe in healthy individuals.
- Behavioural testing: The participant is asked to participate in training
sessions on a computer task, which tests perceptual detection and
decision-making
kampweg 55
Soesterberg 3769DE
NL
kampweg 55
Soesterberg 3769DE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. The potential subject has given informed and written consent and is able to
comply with all study assessmentsscheduled in the protocol.
2. All subjects need to be between 18 and 55 years of age.
3. All subjects have computer skills.
4. All subjects declare to be in good health, and declare not to have any
chronic diseases.
5. Subjects must be able to communicate, participate, and comply with the
requirements of the entire study.
6. No signs of flue or viral infection in the last 5 days before the start.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Pregnancy
2. Atherosclerosis
3. Other cardiovascular health issues
4. Epilepsy and a history of psychiatric illness (including sleeping disorders).
5. Having an active implantable (metallic) device.
6. Using another device at the same time of testing or any portable electronic
device (e.g., mobile phone).
7. Used alcohol the day before the start of a test day.
8. Used drugs in the last 3 months.
Design
Recruitment
Medical products/devices used
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 | NL84460.028.23 |