- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06375395
Boosting The Intervention Effect of Negative Memory Through tACS Stimulation
Research on Improving the Intervention Effect of Negative Memory Through tACS Enhanced Memory Technology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will adopt two memory updating strategies: retrieval practice and reactivation.
A 5-day memory updating experimental paradigm is used.
- On the first day, the old memory A-B linkage is learned, where A represents a neutral word and B is either neutral or negative pictures (half of each, randomly scrambled).
- On the second day, the old memory A-B association is consolidated again, and after a 15-minute break, the new memory A-C association is learned, where A is still the word A used in the old memory A-B association on the first day, and C is the new neutral and negative pictures (half of each, randomly scrambled, and with inconsistent categories of C and B in each pair of AC and AB). Immediately following this, the new memories of the A-C conjunctions are updated using both Retrieval practice and Restudy (control condition) memory strategies.
- A-C is extracted/learned using both Retrieval practice and Restudy memory strategies on both day 3 and day 4.
- On the fifth day, memory tests for associative memory strength, gist and detail memory, as well as emotional valence and strength are performed.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hongxing Wang, MD & PhD
- Phone Number: 01083198513
- Email: hxwang8888@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Eligibility
Inclusion Criteria:
- 14-60 years old, male or female, Han Chinese;
- Drug-resistant epilepsy;
- Required surgical implantation of SEEG electrodes.
Exclusion Criteria:
- Progressive encephalopathy or progressive structural damage in the central nervous system;
- Significant heart, liver, renal insufficiency, and other medical diseases;
- Severe side effects from taking antiepileptic drugs at the time of enrollment and not inappropriate for SEEG;
- Significant intellectual disability;
- A history of alcohol and drug abuse;
- Any contraindication to MRI.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active tACS
Those who participate in the treatment group will receive tACS, which lasts for 40 minutes per day on 3 consecutive days.
|
Transcranial Alternating Current Stimulation
|
|
Placebo Comparator: Sham tACS
Those who participate in the control group will receive sham tACS, which lasts for 40 minutes per day on 3 consecutive days.
|
Placebo Device that simulates active tACS treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Negative memory retention
Time Frame: Day 5
|
The intervention could disrupt retention of associative negative memory and degree of detail of the negative memories in last A-C paired associate memory test.
|
Day 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The negative emotional intensity of negative memory
Time Frame: Day 5
|
The negative memories emotional relief as assesses by the Self-Assessment Manikin (SAM) Measure Scales in last A-C paired associate memory test. This measure is constant retrieval practice of neutral memories (A-Cneu) will result in negative memories emotional relief (A-Bneg) compared to the restudy condition. |
Day 5
|
|
The retention of associated neutral memories as assesses by the proportions of responses of correctly choosing picture category of B picture (A-Bneu) in last A-B paired associate memory test
Time Frame: Day 5
|
This measure is continuous rumination of negative memories (A-Cneg) will increase the strength of associated memories (A-Bneu).
|
Day 5
|
|
The negative emotional intensity of neutral memory
Time Frame: Day 5
|
The emotion-diffusing effects of negative memory rumination as assesses by negative emotional intensity of neutral memories (A-Bneu),which is meature by the Self-Assessment Manikin (SAM) Measure Scales.
The negative emotional intensity of neutral memories are more negative with constant retrieval practice of negative memories (A-Cneg) that is the emotion-diffusing effects of negative memory rumination.
|
Day 5
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Guoguang Zhao, Xuanwu Hospital, Beijing
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Memory Updating Tasks
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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