National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin, 640, Taiwan
Location status: Recruiting
NCT Number: NCT05161819
This is a randomized double-blind sham-controlled crossover study; the interventions are high-frequency rTMS stimulation on left DLPFC and sham control. The study population is the patient with somatic symptom disorder. The primary outcomes are somatic distress and health anxiety.
Interested in participating?
Request Info20 year–70 year
All sexes
Interventional
Not applicable
Douliu, Yunlin, 640, Taiwan
Location status: Recruiting
Somatic symptom disorder (SSD) is a psychiatric diagnosis featured with somatic distress and health anxiety. It is overlapped with functional disorders. Whether it has effective treatment is a clinically important issue. Current evidence indicates that pharmacotherapy and psychotherapy are both helpful for SSD. Among other treatment options, repetitive transcranial magnetic stimulation (rTMS) is attached important in psychiatric field; it can cause activation or inhibition of specific brain regions via magnetic stimulation. Previous studies have disclosed that rTMS is helpful for depression, obsessive-compulsive disorder, post-stroke rehabilitation, etc. Regarding functional disorders, fibromyalgia has been found to be benefited from rTMS; the effective approaches include giving high-frequency stimulation on left M1 and dorsolateral prefrontal cortex (DLPFC). Chronic tinnitus was also found to have response to rTMS. SSD and fibromyalgia are highly overlapped; SSD and depression are often comorbid. Therefore, SSD may also be benefited from left DLPFC high-frequency stimulation. Our previous study revealed that dysfunction of anterior cingulate cortex (ACC) is associated with persistent interference of the somatic discomforts; stimulation on DLPFC can cause ACC activation. This study program was designed based on the above information. It is a randomized double-blind sham-controlled crossover study; the interventions are high-frequency rTMS stimulation on left DLPFC and sham control. The primary outcomes are somatic distress and health anxiety. There is not study about rTMS on SSD in literature; the investigators expect this study to be able to provide more understanding on this field.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)
Time frame: Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress
Time frame: Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety
Time frame: Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)
Measurement of somatic distress. Score range is 0 to 30; higher score means more severe somatic distress
Time frame: Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)
Measurement of health anxiety. Score range is 0 to 63; higher score means more severe health anxiety
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Measurement of depression. Score range is 0 to 63; higher score means more severe depression
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Measurement of anxiety. Score range is 0 to 63; higher score means more severe anxiety
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Measurement of cognitions about health. Score range is 0 to 117; higher score means more severe cognitive distortion about health
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Measurement of parasympathetic activity
Time frame: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)
Measurement of sympathetic activity
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder: A Randomized Double-blind Sham-controlled Crossover Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04899687
Anxiety Disorders, Body Dysmorphic Disorders
Stanford, California, United States
View Trial DetailsNCT05792930
Somatic Symptom Disorder
Yunlin, Taiwan
View Trial DetailsNCT05666921
Affective Symptoms, Behavior
Florence, Firenze, Italy
View Trial DetailsNCT05946512
Post COVID-19 Condition, Somatic Symptom Disorder
Innsbruck, Tyrol, Austria
View Trial Details