Healthy VolunteersFORGETNCT05511480
Reshaping the Motor Engram - An Online Crowdsourcing Study.
A study testing Interference through learning of a competing motor skill. and No interference in people with Healthy Volunteers, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Interference through learning of a competing motor skill. and No interference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- prior participation in this experiment
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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).
- Conditions
- Healthy Volunteers
- Being tested
- Interference through learning of a competing motor skill., No interference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interference through learning of a competing motor skill.Behavioural
Interference through the learning of a competing motor skill.
No interferenceBehavioural
No interference through the continuation of learning same motor skill
| Study group | Role | What they receive |
|---|---|---|
| Interference on sequence 1 | Experimental | The interference intervention (session six) will be applied to one of the two previously learned sequences (temporal). Receives: 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). Receives: 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). Receives: Behavioral: Interference through learning of a competing motor skill. |
| No interference | Sham comparator | The interference intervention (session six) will be applied. Receives: Behavioral: No interference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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].
Measured: seven days
Secondary outcomes (1)
Learning rate (change in performance precision)
Skill learning is defined based on the precision of timing of key presses relative to the occurrence and duration of visual cues presented on the computer screen. Skill learning is indexed by increased precision over time, operationalized as declining deviation of key on- and offsets from the timing of cue on- and offsets. Learning rate is the absolute change of precision over the learning phase of five days, which is expected to follow an asymptotic exponential function.
Measured: five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Aug 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirstin-Friederike Heise, PhD, Medical University of South Carolina
- Investigators
- Kirstin-Friederike Heise, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511480
- Sponsor's protocol ID
- 00118731
- Acronym
- FORGET
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2022
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reshaping the Motor Engram - An Online Crowdsourcing Study.
- ClinicalTrials.gov ID
- NCT05511480
- Acronym / sponsor ID
- FORGET / 00118731
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Interference on sequence 1 | Experimental | Behavioral: Interference through learning of a competing motor skill.The interference intervention (session six) will be applied to one of the two previously learned sequences (temporal). |
| Interference on sequence 2 | Experimental | Behavioral: Interference through learning of a competing motor skill.The interference intervention (session six) will be applied to one of the two previously learned sequences (spatial). |
| Interference on sequences 1 and 2 | Experimental | Behavioral: Interference through learning of a competing motor skill.The interference intervention (session six) will be applied to both of the two previously learned sequences (temporal and spatial). |
| No interference | Sham comparator | Behavioral: No interferenceThe interference intervention (session six) will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- prior participation in this experiment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interference through learning of a competing motor skill.Interference through the learning of a competing motor skill. | Behavioural | Interference on sequence 1, Interference on sequence 2, Interference on sequences 1 and 2 |
| No interferenceNo interference through the continuation of learning same motor skill | Behavioural | No interference |
Primary outcome
Immediate interference rate (change in performance precision)
Time frame: six days
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].
Delayed interference rate (change in performance precision)
Time frame: seven days
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].
1 secondary outcome
Learning rate (change in performance precision)
Time frame: five days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirstin-Friederike Heise, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interference through learning of a competing motor skill. and No interference in people with Healthy Volunteers, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate interference rate (change in performance precision) (time frame: six days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.