Clinical trial NCT05339776: Hand Lateralization by Using EEG Analysis Method in Amputees
Official title: Evaluation of Hand Lateralization Cognitive Task From Different Personal Perspectives by Using EEG Analysis Method in Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Image
Keywords: EEG
mental rotation
hand lateralization
hand recognition
amputees
body schema
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: Medipol University
First posted: 2022-04-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studies on the improvement of body image or body perception have proven their effectiveness in different clinical situations such as pain management and chronic pain treatment. The aim of this study is to evaluate the hand lateralization cognitive task by recording Electroencephalography (EEG) signals from different personal perspectives in amputees. In this study, the paradigm in which personal perspectives are evaluated over the hand lateralization task will be applied to amputees and healthy volunteer participants. Data will be recorded via EEG and Eprime software program.

Detailed description: The aim of this study is to evaluate the hand lateralization cognitive task by recording Electroencephalography (EEG) signals from different personal perspectives in amputees.

In this study, the paradigm in which personal perspectives are evaluated over the hand lateralization task will be applied to amputees and healthy volunteer participants.

It was planned to enroll two groups to the study. One group is named "amputees" the other one is "control". Control group will be matched in terms of age and gender with the amputees group. Before hand lateralization test, participants will be evaluated regarding eligible criterias and EEG paradigm regarding hand lateralization will be performed for each participant.

Both groups (Amputees and Control) will complete "hand lateralization program" for at least 10 days. The test will be sent each day on an online system. Participants' performances will be recorded via online system.

Following 10-day period, EEG paradigm regarding hand lateralization will be performed for each participant, again.

Before and after comparisons will be analyzed. Data will be recorded via EEG and Eprime software program.

EEG-Event Related Oscillation (power spectrum, phase locking) analysis will be performed for each frequency bands: alpha, theta, beta, gamma.

Eprime analysis will be performed for the data of reaction time and accuracy rate.

Eligibility criteria: Control group:

Inclusion Criteria:

* being between ages 18-65,
* consenting,
* with no limitation in mobility or movement disorder,
* A score of 21 or higher on the Montreal Cognitive Assessment Test

Exclusion Criteria:

* refuse to attend to the study,
* Having any mental, neurological or musculoskeletal problems,
* Inability to perform activities that require long-term attention,
* Inability to detect given commands,
* Using sedative drugs and/or derivatives

Amputee group:

Inclusion Criteria:

* between ages 18-65,
* using prosthesis,
* A score of 21 or higher on the Montreal Cognitive Assessment Test

Exclusion Criteria:

* Having phantom pain,
* Having open wound on stump,
* Having any discomfort feeling on stump,
* Having any mental, neurological or musculoskeletal problems,
* Inability to perform activities that require long-term attention,
* Inability to detect given commands,
* Using sedative drugs and/or derivatives

Primary outcomes:
measure: Electroencephalogram (EEG) frequency bands: alpha, theta, beta, gamma
timeFrame: Before and after the hand lateralization test: 10-14 days
Secondary outcomes:
measure: Reaction time to decide whether the hand is right or left
timeFrame: Before and after the hand lateralization test: 10-14 days
measure: Accuracy proportion of given answers regarding hand lateralization
timeFrame: Before and after the hand lateralization test: 10-14 days
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
affiliation: Trakya University
name: Burcu Dilek, PhD
role: PRINCIPAL_INVESTIGATOR
References: