Cause-effect Relationships Between Brain Networks and Bimanual Coordination in Older Adults

NCT04349137 | Unknown

• 1 other identifier: RWS-SV-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, high-definition dual-site transcranial alternating current stimulation (i.e., non-invasive brain stimulation) will be applied to boost the fronto-parietal network during a bimanual coordination task in healthy young and older adults. Previous studies indicated that this network is important in initial motor learning, possibly through its role in spatial working memory. Therefore, stimulation will be applied during both a pure spatial working memory test, and during a bimanual coordination task. It is also shown that healthy older adults do not engage spatial working memory brain regions during motor learning, which is related to worse motor learning. Therefore, the investigators will investigate whether this type of stimulation can improve bimanual motor learning in healthy older adults.

Conditions

Healthy Aging; Healthy

Outcome Measures

Primary Outcomes (15)

• Bimanual Coordination accuracy during the stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the blocks that were executed during the (sham) stimulation.

  day 1

• Bimanual Coordination accuracy during the stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the blocks that were executed during the (sham) stimulation.

  day 25

• Bimanual Coordination accuracy during the stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the blocks that were executed during the (sham) stimulation.

  day 49

• Bimanual Coordination accuracy 15 minutes after stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the retention block that was executed 15min after the (sham) stimulation.

  day 1

• Bimanual Coordination accuracy 15 minutes after stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the retention block that was executed 15min after the (sham) stimulation.

  day 25

• Bimanual Coordination accuracy 15 minutes after stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the retention block that was executed 15min after the (sham) stimulation.

  day 49

• Stability of movement during the stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the blocks that were executed during the (sham) stimulation.

  day 1

• Stability of movement during the stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the blocks that were executed during the (sham) stimulation.

  day 25

• Stability of movement during the stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the blocks that were executed during the (sham) stimulation.

  day 49

• Stability of movement 15 minutes after the stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the retention block that was executed 15min after the (sham) stimulation.

  day 1

• Stability of movement 15 minutes after the stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the retention block that was executed 15min after the (sham) stimulation.

  day 25

• Stability of movement 15 minutes after the stimulation or sham

  This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the retention block that was executed 15min after the (sham) stimulation.

  day 49

• Working Memory during stimulation or sham

  Working memory will be assessed using the sensitivity index. This will be measured in the blocks that were executed during the (sham) stimulation.

  Day 1

• Working Memory during stimulation or sham

  Working memory will be assessed using the sensitivity index. This will be measured in the blocks that were executed during the (sham) stimulation.

  Day 25

• Working Memory during stimulation or sham

  Working memory will be assessed using the sensitivity index. This will be measured in the blocks that were executed during the (sham) stimulation.

  Day 49

Study Arms (3)

In-phase 6Hz tACS

EXPERIMENTAL

Transcranial alternating current stimulation (tACS) will be administered over the right PPC and the right DLPFC in a synchronized (in-phase) manner at a frequency of 6Hz

Device: HD-tACS

Anti-phase 6Hz tACS

ACTIVE COMPARATOR

Transcranial alternating current stimulation (tACS) will be administered over the right PPC and the right DLPFC in a desynchronized (anti-phase, i.e. with a difference of 180deg) manner at a frequency of 6Hz

Device: HD-tACS

Sham tACS

SHAM COMPARATOR

A sham transcranial alternating current stimulation (tACS) will be administered over the right PPC and the right DLPFC at a frequency of 6Hz using physical vibrations instead of electrical current

Device: sham HD-tACS

Interventions

HD-tACS DEVICE

non-invasive high-definition dual-site transcranial alternating current stimulation (HD-tACS) low intensive electrical alternating currents (2 mA peak-to-peak) are externally applied to the skull at a frequency of 6Hz to entrain endogenous neural oscillatory activity.

Anti-phase 6Hz tACS; In-phase 6Hz tACS

sham HD-tACS DEVICE

sham non-invasive high-definition dual-site transcranial alternating current stimulation (HD-tACS)

Sham tACS

Eligibility Criteria

• Age: 65 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Right-handedness
• Normal cognitive functions (\>25 on Montreal Cognitive Assessment Questionnaire)
• Normal vision
• Healthy

You may not qualify if:

• Transcranial Electric Stimulation (TES) is contra-indicated (TES screening questionnaire)
• Neurologic or psychiatric disorders
• Physical disorder(s) that might interfere with the execution of the bimanual motor task
• Alcohol and/or drug addiction
• Active smokers
• Current use of specific drugs that interfere with the central nervous system
• Skin allergies to cosmetics and lotions
• Pregnancy

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Hasselt University

Hasselt, 3500, Belgium

RECRUITING

Study Officials

• Bart Van Wijmeersch, prof. dr.

  Hasselt University

  STUDY DIRECTOR

• Raf Meesen, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Stefanie Verstraelen, drs.

  Hasselt University

  STUDY CHAIR

• Kim van Dun, dr.

  Hasselt University

  STUDY CHAIR

Central Study Contacts

Raf Meesen, prof. dr.

CONTACT

+32 11 26 21 24; raf.meesen@uhasselt.be

Stefanie Verstralen, drs.

CONTACT

+32 11 26 93 61; stefanie.verstraelen@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 16, 2020
• Study Start: November 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)