AzTrials
AzTrials

Working MemoryNCT06469333

Theories of Working Memory and Consolidation/RECOnsolidation in the Process of Resorption of Post-traumatic Symptoms.

A study testing Eye movements (EM), Auditory stimulations and Tactile stimulations in people with Working Memory and Consolidation/Recconsolidation Memory, run by University of Lorraine at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

EMDR is a psychotherapeutic approach recommended by the World Health Organization (WHO) for the treatment of disorders such as post-traumatic stress disorder, anxiety, depression and, more generally, psychological distress. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Eye movements (EM), Auditory stimulations and Tactile stimulations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteFrance
Study dates
6 Sep 2024to 18 Mar 2026
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Present symptoms of acute stress (score between 22 and 35 on the Impact Event Scale-Revised, IES-R) and/or PTSD (higher score or equal to 36 on the IES-R), but at least present moderate to high psychological distress (score equal to or greater than 8 on the Kessler Abbreviated Psychological Distress Scale, K6);
  • Being in need of psychotherapeutic follow-up but not having started it yet;
  • Be aged between 18 and 65 years inclusive;
  • Speak and write French (be able to understand information and complete questionnaires independently);
  • Have good vision (being able to follow the movement of a white point on a screen);
  • Have good hearing and tactile abilities (being able to perceive auditory and tactile tones);
  • Have a computer equipped with a webcam;
  • Be informed and sign informed consent.

Who cannot join

  • Be an adult protected under guardianship or curatorship;
  • Be a person subject to a judicial safeguard measure;
  • Present a lack of autonomy implying an impossibility in terms of administering questionnaires and filling out questionnaires;
  • Have a vision defect implying an impossibility of visual tracking of a white dot;
  • Present a hearing defect and/or tactile abilities implying an impossibility of perception;
  • Have a neurological condition constituting measurement biases (muscular dysfunctions, perceptual dysfunctions, etc.);
Show all 11Show fewer
  • Suffer from psychotraumatic and dissociative disorders of complex type (respectively evaluated with regard to the anamestistic data of the patients and with a score greater than 25 on the dissociative experiences scale (Dissociative Experiences Scale, DES);
  • Do not present psychological distress (score less than 8 on the Kessler Abbreviated Psychological Distress Scale, K6) ;
  • Have a drug or alcohol dependence;
  • Benefit from ongoing psychotherapeutic monitoring;
  • Have already benefited from psychotherapeutic follow-up or have participated in studies in the last 6 months, both involving EMDR therapy.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Umr U1319 Inspiire

    Vandœuvre-lès-Nancy, 54505

Other trials in France

About this study

Official title: Theories of Working Memory and Consolidation/RECOnsolidation in the Process of Resorption of Certain Post-traumatic Symptoms: Interventional, Randomized Single-center Study

EMDR is a psychotherapeutic approach recommended by the World Health Organization (WHO) for the treatment of disorders such as post-traumatic stress disorder, anxiety, depression and, more generally, psychological distress. In all these disorders, intrusions are one of the symptoms leading to intense emotional distress. EMDR therapy, by making intrusions less emotional and less present in the mind (i.e. less vivid), would reduce psychological distress. This symptomatological reduction would be made possible by the therapist's application of alternating bilateral visual (rapid eye movements following a point from left to right), auditory (tones emitted alternately in the right ear and then in the left ear) and/or tactile (tapping with fingers on the left and right shoulders alternately) stimulations administered while the patient concentrates on his or her intrusive thoughts. Accordingly, the aim of this research is to investigate the efficacy of self-administration of Alternating Bilateral Stimulations (ABS), on the emotional intensity (emotionality) associated with negative intrusive thoughts (or intrusions).

Read the detailed description

Intrusive thoughts (or intrusions) are recognized as being particularly vivid and emotionally "charged", and constitute one of the transdiagnostic symptoms of numerous disorders such as Post Traumatic Stress Disorder (PTSD), anxiety and depression.

Numerous studies have demonstrated that it is now possible to modulate the persistence of intrusions in memory, as well as their emotional impact, through Eye Movement Desensitization and Reprocessing (EMDR) therapy. EMDR is based on the administration of visual, auditory (sound) or sensory (tapping) Alternating Bilateral Stimulations (ABS). These ABS, which can be self-administered by the patient during the Memory Activation (MA) of an intrusive thought, would reduce the emotionality and vividness of the intrusive symptoms and decrease the associated physiological reactivity.

Recent research claims that the mechanisms of action of ABS involve a joint articulation of both neurobiological (Memory Consolidation/Reconsolidation (M-C/R) and psychological (Working Memory (WM)) theories.

Memory consolidation refers to the transfer of a newly acquired memory trace into WM (fragile and susceptible to forgetting) and its stabilization in Long-Term Memory (LTM). Consolidation involves two processes. The first, synaptic consolidation, requires the triggering of molecular processes operating within a time window of between 10 minutes and 6 hours. The second, called systemic consolidation, can extend over years and takes place mainly during the sleep cycle. Reconsolidation implies that an intrusion, when activated in WM, becomes labile again and must subsequently be consolidated again (reconsolidated) in LTM. A permanent memory can thus be revived, then degraded, notably by the administration of ABS likely to interfere with its reconsolidation in memory.

Working memory (WM) refers to a memory system that enables the temporary retention and processing of information needed to perform complex cognitive tasks. capacity is limited. In fact, the competition of two simultaneous tasks (e.g. BAS administration during the memory activation (MA) of an intrusive thought) implies, in a consequential way, an alteration in its storage performance, as well as a decrease in the emotional load associated with the intrusion. In other words, while WM remains the strongest lead to date, it can only be considered in conjunction with M-C/R theory.

From a clinical/experimental protocol point of view, this link implies compliance with a number of criteria. The first is the temporal criterion for ABS administration (between 10 minutes and 6 hours post-MA), as well as the quantitative criterion relating to the number of MAs (not to exceed 4 MAs). In other words, the application of an interventional methodology that does not meet all these criteria (i.e., administration of ABS performed outside the M-C/R time window and repeated MA of the same intrusion) would induce the involvement of a third process, namely the extinction process. In one study, the application of an extinction protocol performed within the consolidation window (a paradigm known as Retrieval Extinction (P-R/E)) also induced a modification of the initial memory trace. It would therefore seem appropriate to consider the adoption of a tri-processual integrative model involving the joint articulation of Working Memory (WM), Memory Consolidation/Reconsolidation (C/R-M) and the Retrieval Extinction Paradigm (P-R/E). This is why we propose to study, in this research , the role of the application of this tri-processual theoretical modeling on the emotionality and vividness associated with intrusions, as well as on their psychophysiological and psychopathological consequences. Through the use of new technologies, these methodologies could complement conventional psychotherapeutic treatments which, through the self-administration of ABS, could add up and, in fact, potentiate the effectiveness of psychotherapy.

Being tested
Eye movements (EM), Auditory stimulations, Tactile stimulations
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eye movements (EM)Behavioural

    The participant focuses on the intrusive thought and visually follows the horizontal movement of a white dot (Ø 1 cm) on the black computer screen 8 times for 24 seconds.

  • Auditory stimulationsBehavioural

    The participant focuses on the intrusive thoughts and hears the auditory "beeps" through the headphones provided 8 times for 24 seconds.

  • Tactile stimulationsBehavioural

    The participant focuses on the intrusive thought and applies tactile self-stimulation 8 times for 24 seconds.

Study groups in NCT06469333
Study groupRoleWhat they receive
Control GroupNo interventionThe participant is asked to concentrate on the image or, failing that, the sensory representation representing the worst aspect of the targeted intrusive thought for 10 seconds, and to stare at the black computer screen.
Eye movements (EM)ExperimentalThe participant is asked to focus on the image or, failing that, the sensory representation representing the worst aspect of the targeted intrusive thought for 10 seconds and visually follow the horizontal displacement of a white dot (Ø 1cm) on the black screen at a constant speed of 1.2 Hz. This speed, implying the displacement of 1.2 left-right-left cycles per second, targets the saturation of working memory.
Receives: Behavioral: Eye movements (EM)
Eye movements and auditory stimulations (EM+AS)ExperimentalThe participant will have to concentrate on the image or, failing that, the sensory representation representing the worst aspect of the targeted intrusive thought for 10 seconds and follow the horizontal displacement of a white dot on the computer screen, while simultaneously perceiving the auditory "beep" tones in the headphones provided. These tones will be at a rate of 1.2 Hz (i.e. 1.2 left ear-right ear-left ear alternations per second).
Receives: Behavioral: Eye movements (EM); Behavioral: Auditory stimulations
Eye movements, auditory stimulations and tactile stimulations (EM+AS+TS)ExperimentalThe participant is asked to concentrate on the image or, failing that, the sensory representation representing the worst aspect of the targeted intrusive thought for 10 seconds, and to follow the horizontal displacement of a white dot on the computer screen and simultaneously perceive the "beeps", as well as the tactile self-stimulations applied at a constant speed of 1.2Hz (i.e. 1.2 left-right-left tapping cycles per second).
Receives: Behavioral: Eye movements (EM); Behavioral: Auditory stimulations; Behavioral: Tactile stimulations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of emotionality associated with an intrusive thought

    Emotionality will be assessed using the Subjective Units of Disturbance Scale (SUDS), which ranges from 0 ("no distress at all") to 10 ("maximum distress") and provides a subjective assessment of the disturbance associated with the intrusive thought.

    Measured: Before and after the experimental phase (7 days after Day 1), The first day after the experimental phase and one night's sleep (comprising 4 to 6 sleep cycles with an average duration of 90 minutes ), through study completion (21 days after D1)

Secondary outcomes (4)
  1. Assessment of the vividness of the intrusion

    Vividness will be assessed via an analogous 11-point numerical scale ranging from 0 ("not vivid at all") to 10 ("extremely vivid"). This measure is frequently used in experimental research involving the application of a double task

    Measured: Before and after the experimental phase (7 days after Day 1), The first day after the experimental phase and one night's sleep (comprising 4 to 6 sleep cycles with an average duration of 90 minutes ), through study completion (21 days after D1)

  2. Psychological distress

    Psychological distress will be assessed using Kessler's Abbreviated Scale of Psychological Distress. This 6-item scale assesses the frequency of occurrence over the past month of anxiety-depressive emotional states and non-specific psychological distress. On a 5-point scale ranging from 0 "never" to 4 "all the time", the subject is asked to indicate how often he or she felt "nervous", "hopeless", "restless or out of place", "so depressed that nothing could make him or her smile", "that everything was an effort" and that he or she was "good for nothing". The total score obtained ranged from 0 to 24. According to the authors, a total score between 0 and 7 indicates low-intensity distress, a score of 8 to 12 indicates moderate distress, and a score of 13 or above indicates severe psychological distress.

    Measured: At day 1 (D1), before the experimental phase (7 days after Day 1), The first day after the experimental phase and one night's sleep (comprising 4 to 6 sleep cycles with an average duration of 90 minutes ), through study completion (21 days after D1)

  3. Intrusion symptoms

    Symptoms of intrusion will be measured using the Impact of Event Scale-Revised (IES-R). The IES-R is a 22-item scale measuring symptoms of intrusion (dreams about the event), avoidance/blunting (efforts to avoid reminders of the event) and hyperactivation (hypervigilance) in relation to a specific life-threatening event. The subject is asked to indicate on a 5-point Likert scale, from 0 "Not at all" to 4 "Extremely", how upset he or she may have been by difficulties relating to a specific stressful event over the past 7 days. The authors agree that a total score of 22 suggests the presence of acute stress, and a score of 36 indicates the presence of PTSD.

    Measured: At day 1 (D1), the first day after the experimental phase and one night's sleep (comprising 4 to 6 sleep cycles with an average duration of 90 minutes ) , through study completion (21 days after D1).

  4. Nature, impact and severity of insomnia

    Insomnia will be measured by the Insomnia Severity Index (ISI) self-report questionnaire. This questionnaire consists of 7 items rated on a 5-point Likert scale. The total score, ranging from 0 to 28, is obtained by adding the scores of the 7 items. A high score of 28 or more indicates severe insomnia; a score of 15 to 21 indicates moderate insomnia; a score of 8 to 14 indicates sub-clinical insomnia. Finally, a score of 7 or less means no insomnia.

    Measured: the first day after the experimental phase and one night's sleep (comprising 4 to 6 sleep cycles with an average duration of 90 minutes )

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2024
  2. Study start6 Sep 2024
  3. Primary completion18 Mar 2026
  4. Study completion18 Mar 2026

Resources

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
Single blind
Who is masked
Participant
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06469333
Sponsor's protocol ID
2024-A00296-41
Status last verified
Oct 2026
First submitted
5 Jun 2024
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Eye movements (EM), Auditory stimulations and Tactile stimulations in people with Working Memory and Consolidation/Recconsolidation Memory, run by University of Lorraine at 1 site in France.

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 8 inclusion and 11 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 9 Oct 2026. 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 France. 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. 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?

Measurement of emotionality associated with an intrusive thought (time frame: Before and after the experimental phase (7 days after Day 1), The first day after the experimental phase and one night's sleep (comprising 4 to 6 sleep cycles with an average duration of 90 minutes ), through study completion (21 days after D1)). 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 9 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in