SeizuresNCT06375395
Boosting The Intervention Effect of Negative Memory Through tACS Stimulation
A study testing Active tACS Device in people with Seizures, run by Xuanwu Hospital, Beijing.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Seizures
- What is being tested?
- Active tACS Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 31 Dec 2024
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14-60 years old, male or female, Han Chinese;
- Drug-resistant epilepsy;
- Required surgical implantation of SEEG electrodes.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Research on Improving the Intervention Effect of Negative Memory Through tACS Enhanced Memory Technology
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.
Read the 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.
- Conditions
- Seizures
- Being tested
- Active tACS Device, Sham tACS Device
- Keywords
- seizure, transcranial alternating current stimulation, neuromodulation, negative memory, neural mechanisms, retrieval practice, working memory
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tACS DeviceDevice
Transcranial Alternating Current Stimulation
Sham tACS DeviceDevice
Placebo Device that simulates active tACS treatment
| Study group | Role | What they receive |
|---|---|---|
| Active tACS | Experimental | Those who participate in the treatment group will receive tACS, which lasts for 40 minutes per day on 3 consecutive days. Receives: 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. Receives: Device: Sham tACS Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 5
Secondary outcomes (3)
The negative emotional intensity of negative memory
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.
Measured: 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
This measure is continuous rumination of negative memories (A-Cneg) will increase the strength of associated memories (A-Bneu).
Measured: Day 5
The negative emotional intensity of neutral memory
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.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Normal University
- Responsible party
- Sponsor
- Investigators
- Guoguang Zhao, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375395
- Sponsor's protocol ID
- Memory Updating Tasks
- Status last verified
- Nov 2023
- First submitted
- 1 Jan 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Improving the Intervention Effect of Negative Memory Through tACS Enhanced Memory Technology
- ClinicalTrials.gov ID
- NCT06375395
- Acronym / sponsor ID
- Memory Updating Tasks
- Conditions
- Seizures
- Keywords
- seizure, transcranial alternating current stimulation, neuromodulation, negative memory, neural mechanisms, retrieval practice, working memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Normal University
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Apr 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tACS | Experimental | Device: Active tACS DeviceThose who participate in the treatment group will receive tACS, which lasts for 40 minutes per day on 3 consecutive days. |
| Sham tACS | Placebo comparator | Device: Sham tACS DeviceThose who participate in the control group will receive sham tACS, which lasts for 40 minutes per day on 3 consecutive days. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 14-60 years old, male or female, Han Chinese;
- Drug-resistant epilepsy;
- Required surgical implantation of SEEG electrodes.
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| Active tACS DeviceTranscranial Alternating Current Stimulation | Device | Active tACS |
| Sham tACS DevicePlacebo Device that simulates active tACS treatment | Device | Sham tACS |
Primary outcome
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.
3 secondary outcomes
The negative emotional intensity of negative memory
Time frame: 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
The negative emotional intensity of neutral memory
Time frame: Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Guoguang Zhao study director
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A study testing Active tACS Device in people with Seizures, run by Xuanwu Hospital, Beijing.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongxing Wang, MD & PhD (01083198513, hxwang8888@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative memory retention (time frame: Day 5). 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 7 Aug 2024.