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Completed

NCT Number: NCT05339776

Hand Lateralization by Using EEG Analysis Method in Amputees

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trakya University

Edirne, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand Lateralization Test

Behavioral

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.

Primary outcomes

  1. Electroencephalogram (EEG) frequency bands: alpha, theta, beta, gamma

    Time frame: Before and after the hand lateralization test: 10-14 days

    Changes in power spectrum and phase locking

Secondary outcomes

  1. Reaction time to decide whether the hand is right or left

    Time frame: Before and after the hand lateralization test: 10-14 days

    E-prime parameter: recorded as milisecond

  2. Accuracy proportion of given answers regarding hand lateralization

    Time frame: Before and after the hand lateralization test: 10-14 days

    E-prime parameter: recorded as percentage

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Collaborators

  • Medipol University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 21, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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