- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07550556
Neural Basis of the Effect of EMDR Therapy (EMDR-NEURO)
Neural Basis of the Effect of Eye Movement Desensitization and Reprocessing (EMDR) Therapy on Cognition in Patients With Post-Traumatic Stress Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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RM
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Rome, RM, Italy, 00135
- University of Rome Foro Italico
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- normal or corrected-to-normal vision; full right-handedness
Exclusion Criteria:
- neurological or other psychiatric disorders tha PTSD; current use of psychoactive medications.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Butterfly Tapping
Participants assigned to the Experimental Group (Exp) will perform a self-administered session of Butterfly Tapping (BT), a form of alternating bilateral tactile stimulation widely used in Eye Movement Desensitization and Reprocessing (EMDR)-derived affect-regulation techniques.
This arm was designed to test whether rhythmic bilateral sensory input modulates neural indices of emotional reactivity.
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Participants adopted the traditional butterfly hug posture: arms crossed over the chest, fingertips placed below the clavicles. They delivered alternating left-right rhythmic taps (~1 Hz) on their shoulders. Eyes remained closed, and participants were instructed to keep the emotional content active by mentally recalling previously viewed negative images, ensuring sustained affective engagement. Duration: 15 minutes, structured in four blocks of 3 minutes with short pauses. No auditory pacing was provided to preserve spontaneous rhythmicity. Targeted Mechanism Bilateral tactile stimulation aiming to modulate cortico-limbic processing, interhemispheric communication, and sustained emotional reactivity, as indexed by LPP amplitude during ta emotional simple response task
Other Names:
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Sham Comparator: No tapping (Control Group)
Participants assigned to the Control Group will maintain the same posture as the experimental group but will not perform any tapping.
This static condition controls for posture, context, expectancy, and emotional activation, isolating the specific effect of the bilateral stimulation.
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Participants will adopt the same butterfly-hug position, with arms crossed and hands placed on the chest. No rhythmic tapping or movements will be performed. Eyes are closed for the entire session, as in the experimental arm. Participants will held the emotional images in mind just as in the experimental arm. Duration: 15 minutes, identical block structure and timing as the BT condition. Targeted Mechanism Serves as a posture-matched and expectancy-matched control, ruling out effects of: simple stillness, emotional recall, attentional focus, physical posture, general relaxation effects.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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LPP
Time Frame: Baseline, End of Treatment (8-12 weeks), and Follow-up (8 weeks after treatment completion)
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Late Positive Potential (LPP) Differential Amplitude (Negative - Neutral) The primary neurophysiological outcome will be the modulation of the centro-parietal Late Positive Potential (LPP), extracted from EEG recordings during the Emotional Simple Response Task (E-SRT). The LPP is a well-established marker of sustained attentional and evaluative processing of emotional stimuli. For each participant and time point (T0, T1, T2), ERP waveforms willbe computed separately for negative and neutral images, and difference waves (negative minus neutral) were used to isolate emotion-specific neural reactivity. Primary analyses focused on mean amplitudes in the experimentally defined cLPP time window (456-552 ms) over the centro-parietal electrode cluster (Cz, C1, C2, CP1, CPz, CP2). The primary contrast of interest was the Group × Time interaction, assessing whether a single session of Butterfly Tapping selectively reduced the LPP differential amplitude relative to the static control condition. |
Baseline, End of Treatment (8-12 weeks), and Follow-up (8 weeks after treatment completion)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frontal positivity
Time Frame: Baseline, End of Treatment (8-12 weeks), and Follow-up (8 weeks after treatment completion)
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Frontal Positivity (188-228 ms).
Is sn exploratory secondary marker, indexing early evaluative or response-related processing, quantified over the frontal region (F1, Fz, F2, FC1, FCz, FC2).
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Baseline, End of Treatment (8-12 weeks), and Follow-up (8 weeks after treatment completion)
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Behavior
Time Frame: Baseline, End of Treatment (8-12 weeks), and Follow-up (8 weeks after treatment completion)
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Behavioral Performance: Response Time (RT) to emotional images Omission Rate (OM) Both extracted from the E-SRT before and after stimulation. |
Baseline, End of Treatment (8-12 weeks), and Follow-up (8 weeks after treatment completion)
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Self-report
Time Frame: Baseline, End of Treatment (8-12 weeks), and Follow-up (8 weeks after treatment completion)
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Self-Reported Emotional State: State Anxiety (STAI-Y1) Emotional Discomfort (VAS) Collected immediately after each task block to assess subjective affective changes. |
Baseline, End of Treatment (8-12 weeks), and Follow-up (8 weeks after treatment completion)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- URomeForoItalico
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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