Hand Lateralization by Using EEG Analysis Method in Amputees

Body Image Clinical Trial

Official title:

Evaluation of Hand Lateralization Cognitive Task From Different Personal Perspectives by Using EEG Analysis Method in Amputees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05339776
• Other study ID #: E-10840098-772.02-6568
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 27, 2023

Study information

• Verified date: September 2023
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 27, 2023
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Image

Intervention

Behavioral:
• Hand Lateralization Test
Before hand lateralization test, participants will be evaluated. Both groups (Amputees and Control) will complete hand lateralization test for at least 10 days. The test will be sent each day on an online system. Participants' performances will be recorded via online system. After hand lateralization test, participants will be evaluated.

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne

Sponsors (2)

Lead Sponsor	Collaborator
Trakya University	Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroencephalogram (EEG) frequency bands: alpha, theta, beta, gamma	Changes in power spectrum and phase locking	Before and after the hand lateralization test: 10-14 days
Secondary	Reaction time to decide whether the hand is right or left	E-prime parameter: recorded as milisecond	Before and after the hand lateralization test: 10-14 days
Secondary	Accuracy proportion of given answers regarding hand lateralization	E-prime parameter: recorded as percentage	Before and after the hand lateralization test: 10-14 days