- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05946616
Spectral Characteristics of Memory Transformation (MEM_MOD)
July 7, 2023 updated by: Kirstin-Friederike Heise, PhD, Medical University of South Carolina
Probing Mechanisms of Procedural Memory Transformation With Cross-frequency Transcranial Alternating Current Stimulation (Cf-tACS) as an Avenue to Sculpt Sensorimotor Behavior
Sometimes, it is necessary to re-learn a previously learned movement behavior, for example, a bad posture during the golf drive or while playing the piano.
Unlearning or relearning an intensively trained behavior is particularly important if the behavior is hampering recovery, for example, in chronic pain or after a stroke.
With this pilot study, the brain mechanisms that control the change of pre-existing stable memories of a motor skill will be tested with electroencephalography (EEG).
Non-invasive brain stimulation will be used to modulate these brain mechanisms and test if it is possible to change the pre-existing motor memory and the learning of a new motor skill.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kirstin-Friederike Heise, PhD
- Phone Number: 3435 (843)792-
- Email: heisek@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Contact:
- Kirstin-Friederike Heise, PhD
- Phone Number: 843-792-3435
- Email: heisek@musc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age 18 years or older (2/3 of the final sample will be ≥60years of age)
- No previous stroke, brain tumor, neurodegenerative disease, or trauma to the head
- Ability to give consent for study participation
- who have access to a personal computer with internet
Exclusion Criteria:
• Pregnancy
- Inability to use all ten fingers to type on a standard computer keyboard
- Uncorrected vision, hindering perception of visual cues presented on a standard computer screen
- Medication use at the time of study that may interfere with learning or the effect of tACS, including but not limited to carbamazepine, flunarizine, sulpiride, rivastigmine, dextromethorphan;
- Neuromuscular disorders affecting hand and finger movements necessary for 10-finger keyboard typing
- Presence of neurological or psychiatric disorders
- Presence of scalp injury or disease
- Prior history of seizures
- Prior intracranial surgery
- Prior brain radiotherapy
- Prior history of intracranial tumor, intracranial infection, or cerebrovascular malformation
- Metal in head or neck
- Contraindications to MRI (such as severe claustrophobia, implanted medical devices)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active non-invasive brain stimulation during behavioral memory interference
Non-invasive brain stimulation with transcranial alternating current stimulation will be applied during a memory interference intervention.
|
Transcranial alternating current stimulation (tACS) combined with behavioral intervention (memory interference).
|
Sham Comparator: Sham stimulation during behavioral memory interference
Inactive (sham) stimulation will be applied during a memory interference intervention.
|
Inactive (sham) stimulation combined with behavioral intervention (memory interference)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral: interference rate
Time Frame: before - after one single intervention (1 hour)
|
Change in performance precision of a previously learned sensorimotor skill
|
before - after one single intervention (1 hour)
|
Neural: brain connectivity change
Time Frame: before - after one single intervention (1 hour)
|
Change in EEG-derived markers of brain activation and connectivity
|
before - after one single intervention (1 hour)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral: interference rate
Time Frame: before - after one single intervention (24 hour follow-up)
|
Change in performance precision of a previously learned sensorimotor skill
|
before - after one single intervention (24 hour follow-up)
|
Neural: brain connectivity change
Time Frame: before - after one single intervention (24 hour follow-up)
|
Change in EEG-derived markers of brain activation and connectivity
|
before - after one single intervention (24 hour follow-up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kirstin-Friederike Heise, PhD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2023
Primary Completion (Estimated)
March 31, 2024
Study Completion (Estimated)
March 31, 2024
Study Registration Dates
First Submitted
June 30, 2023
First Submitted That Met QC Criteria
July 7, 2023
First Posted (Actual)
July 14, 2023
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
July 7, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 00126392
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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