NCT06375395

Brief Summary

The objectives of this study include: 1) investigating the impact of negative memory substitution on an individual's other intellectual memories (i.e., neutral memories) and the underlying neurocognitive mechanisms; 2) investigating the memory enhancement effect resulting from retrieval practice associated with memory substitution intervention along with an examination of the neurocognitive mechanisms responsible for this enhancement.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 7, 2024

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

January 1, 2024

Last Update Submit

August 5, 2024

Conditions

Keywords

seizuretranscranial alternating current stimulationneuromodulationnegative memoryneural mechanismsretrieval practiceworking memory

Outcome Measures

Primary Outcomes (1)

  • Negative memory retention

    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 Outcomes (3)

  • The negative emotional intensity of negative memory

    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

    Day 5

  • The negative emotional intensity of neutral memory

    Day 5

Study Arms (2)

Active tACS

EXPERIMENTAL

Those who participate in the treatment group will receive tACS, which lasts for 40 minutes per day on 3 consecutive days.

Device: Active tACS Device

Sham tACS

PLACEBO COMPARATOR

Those who participate in the control group will receive sham tACS, which lasts for 40 minutes per day on 3 consecutive days.

Device: Sham tACS Device

Interventions

Transcranial Alternating Current Stimulation

Active tACS

Placebo Device that simulates active tACS treatment

Sham tACS

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old, male or female, Han Chinese;
  • Drug-resistant epilepsy;
  • Required surgical implantation of SEEG electrodes.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guoguang Zhao

    Xuanwu Hospital, Beijing

    STUDY DIRECTOR

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2024

First Posted

April 19, 2024

Study Start

August 15, 2024

Primary Completion

December 15, 2024

Study Completion

December 31, 2024

Last Updated

August 7, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share