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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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).

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Post-traumatic stress symptoms — Assessment at baseline, immediately after treatment and one month follow-up
  Post-traumatic stress symptomatology will be assessed using the Revised Impact of Event Scale (IES-R), a 22-item self-report instrument designed to measure subjective distress associated with traumatic or highly stressful events. The scale evaluates three core dimensions: intrusion, avoidance, and hyperarousal. In the present study, the IES-R will be used both to quantify the severity of post-traumatic stress symptoms and to establish eligibility criteria.

Trial sites (2)

More Servicio Canario de Salud trials in Spain