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NOT YET RECRUITING
NCT07567261
NA

Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation and Expressive Writing for Post-Traumatic Stress

Sponsor: Servicio Canario de Salud

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if a combined treatment using repetitive transcranial magnetic stimulation (rTMS) and expressive writing works to reduce symptoms of post-traumatic stress in adults. It will also study how safe this treatment is and whether the timing of rTMS changes how well it works. The main questions it aims to answer are: * Does this combined treatment lower symptoms of post-traumatic stress? * Does it work better when rTMS is given before or after expressive writing? Researchers will compare three groups to see which approach works best: * rTMS given before expressive writing * rTMS given after expressive writing * Sham stimulation (a look-alike procedure that does not provide real stimulation) Participants will: * Take part in sessions that include expressive writing about emotional experiences * Receive either real rTMS or sham stimulation * Complete questionnaires about post-traumatic stress, anxiety, depression, and mood * Have their heart rate and skin responses measured during the sessions * Be assessed before the study, after the sessions, and one month later This study includes adults aged 18 to 65 who have experienced at least one traumatic or highly stressful event and report symptoms of post-traumatic stress.

Official title: Efficacy and Safety of a Combined Intervention of Repetitive Transcranial Magnetic Stimulation and Expressive Writing According to Timing of Administration: A Parallel-Group Randomized Controlled Trial in Adults With Post-Traumatic Stress Symptoms

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-06

Completion Date

2027-02

Last Updated

2026-05-05

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Repetitive Transcranial Magnetic Stimulation

rTMS will be administered by an experienced technician using a figure-of-eight coil connected to a Magstim Rapid2 stimulator (Magstim, Whitland, Dyfed, United Kingdom). Target localization will be performed using stereotactic neuronavigation with the frameless BrainSight system (Rogue Research, Canada) and a Polaris infrared tracking system (Northern Digital, Canada). Before each session and for each participant, the motor hotspot and resting motor threshold (rMT) will be determined. The hotspot will be defined as the stimulation site over the left primary motor cortex that produces the strongest and most consistent motor-evoked potentials in the first dorsal interosseous muscle, recorded via electromyography using a Biopac MP-35 system. The resting motor threshold will be defined as the minimum stimulation intensity capable of eliciting at least five small-amplitude motor responses out of ten stimuli applied to the relaxed muscle. The rTMS intensity will be individually adjusted

BEHAVIORAL

Expressive writing

Emotional re-experiencing will be induced through expressive writing. Participants will write for 15 minutes once per week about the thoughts and emotions associated with their traumatic or highly stressful experiences throughout the treatment period (Pennebaker \& Chung, 2011).

DEVICE

Sham rTMS

Sham stimulation will be delivered using a placebo coil that reproduces the acoustic and procedural characteristics of rTMS without producing effective cortical stimulation.

Locations (2)

Instituto Universitario de Neurociencias (IUNE) de la Universidad de La Laguna (ULL)

San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

Servicio de Evaluación del Servicio Canario de Salud

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain