NCT05511480

Brief Summary

A critical point in learning and memory research is whether memories, once consolidated, remain unchanged or whether they continue to undergo plastic changes and remodeling. While previous research has focused on experimental destabilization during early stages of the memory life cycle, i.e., during encoding or early consolidation, experimental data that provides information about the effect of destabilization interventions on well-consolidated memories is still missing. This is particularly true for the procedural memory domain, such as learning a sensorimotor skill. This project is designed to characterize the effect of a single behavioral interference intervention on a previously consolidated sensorimotor skill in a large sample of healthy volunteers recruited through an online crowdsourcing platform. In a longitudinal design, participants will perform an implicit sequence learning task over five consecutive sessions, followed by an interference intervention in session six and a follow-up evaluation of the stability of the learned skill in session seven. The experimental design includes two levels of sequential information (spatial and temporal), which allows the testing of the specificity of the interference intervention. Behavioral performance throughout the experimental sessions is acquired via the manual input on the participants' computer keyboards and used to extract the learning rate and the interference effect (primary outcome).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

August 11, 2022

Last Update Submit

August 14, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Immediate interference rate (change in performance precision)

    Performance in the learning task is derived from the precision of timing of key presses relative to the occurrence and duration of visual cues presented on the computer screen. The interference rate is operationalized as the change in performance precision over time. The immediate interference effect is analyzed based on the change in performance from before (pre-interference) the interference intervention to directly after the interference intervention in session six (post-interference). This change is normalized to the performance at baseline (pre-interference session six) and computed as \[(post-interference - pre-interference)/pre-interference\*100\].

    six days

  • Delayed interference rate (change in performance precision)

    The delayed interference rate is calculated in analogy to the immediate interference effects with a 24-hours latency of the post-interference measure. Delayed interference is analyzed based on the change in performance from before the interference intervention (pre-interference in session six) to 24 hours after the interference intervention in session seven (24hours post-interference). This change is normalized to the performance at baseline (pre-interference session six) and computed as \[(24 hours post-interference - pre-interference)/pre-interference\*100\].

    seven days

Secondary Outcomes (1)

  • Learning rate (change in performance precision)

    five days

Study Arms (4)

Interference on sequence 1

EXPERIMENTAL

The interference intervention (session six) will be applied to one of the two previously learned sequences (temporal).

Behavioral: Interference through learning of a competing motor skill.

Interference on sequence 2

EXPERIMENTAL

The interference intervention (session six) will be applied to one of the two previously learned sequences (spatial).

Behavioral: Interference through learning of a competing motor skill.

Interference on sequences 1 and 2

EXPERIMENTAL

The interference intervention (session six) will be applied to both of the two previously learned sequences (temporal and spatial).

Behavioral: Interference through learning of a competing motor skill.

No interference

SHAM COMPARATOR

The interference intervention (session six) will be applied.

Behavioral: No interference

Interventions

Interference through the learning of a competing motor skill.

Interference on sequence 1Interference on sequence 2Interference on sequences 1 and 2
No interferenceBEHAVIORAL

No interference through the continuation of learning same motor skill

No interference

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • registered Amazon Mechanical Turk users (called 'workers')
  • with \>95% approval rate on all previous Amazon Mechanical Turk assignments
  • location in North America or Europe
  • ≥18 years of age
  • not having participated in this experiment before

You may not qualify if:

  • prior participation in this experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Officials

  • Kirstin-Friederike Heise, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 23, 2022

Study Start

August 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations