Hand Lateralization by Using EEG Analysis Method in Amputees

Not Applicable

Completed

• Conditions: Body Image
• Interventions: Behavioral: Hand Lateralization Test

• Registration Number: NCT05339776
• Lead Sponsor: Trakya University

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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-21
• Primary Completion: 2022-08-26
• Study Completion: 2023-03-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One of groups: control group	Hand Lateralization Test	Control group will be matched in terms of age and gender with the amputees group.
One of groups: amputees group	Hand Lateralization Test	We planned to enroll two groups to the study. One group is named "amputees" the other one is "control". Both groups will enroll "hand lateralization" for at least 10 days. Before and after comparisons will be analyzed.

Primary Outcome Measures

Name	Time	Method
Electroencephalogram (EEG) frequency bands: alpha, theta, beta, gamma	Before and after the hand lateralization test: 10-14 days	Changes in power spectrum and phase locking

Secondary Outcome Measures

Name	Time	Method
Reaction time to decide whether the hand is right or left	Before and after the hand lateralization test: 10-14 days	E-prime parameter: recorded as milisecond
Accuracy proportion of given answers regarding hand lateralization	Before and after the hand lateralization test: 10-14 days	E-prime parameter: recorded as percentage

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, Turkey