aiTBS for Relieving NSSI in Depressive Patients
Study Details
Study Description
Brief Summary
Repetitive transcranial magnetic stimulation (rTMS) has been successfully used to help patients with treatment resistant depression. However, its role in alleviating self injuries without suicidal ideation remained uncertain. This trial will compare the effectiveness of active accelerated intermittent theta burst stimulation (aiTBS) rTMS to a placebo control on non-suicidal self injury (NSSI) in patients with unipolar disorder and bipolar disorder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study will evaluate the efficacy and safety of aiTBS in unipolar and bipolar depressive patients with NSSI or suicidal thoughts and behaviors by measuring changes in clinical ratings at baseline, after all the treatments, and 2 weeks, 4 weeks after treatment. 60 inpatients will be randomized to receive active or sham interventions administered to the left dorso-lateral prefrontal cortex. The treatment will apply active aiTBS rTMS involving 1620 pulses (9 minutes), 5x daily at 60 minutes intervals for 5 days. Changes in mood and sleep from baseline to the end of the study will be measured with The Hamilton Rating Scale for Depression-17 item (HAM-D17), Hamilton Anxiety Scale (HAMA), Young's Mania Scale (YMRS), and Pittsburgh Sleep Quality Index (PSQI) . Non-suicidal self injury will be assessed by the Deliberate Self-Harm Inventory (DSHI) and the Ottawa self-injury inventory (OSI). Suicidal ideation and behaviors assessments include Beck Suicidal Scale Inventory (BSI) and several questions from Self-Injurious Thoughts and Behaviors Interivew - Revised (SITBI-R). Improvement of cognitive dysfunction could be measured by Barratt Impulsiveness Scale-11 (BIS-11), near infrared spectroscopy (fNIRS) and eye tracking (ET). Treatment Emergent Symptom Scale (TESS) would be used to eliminate side effects of combined drugs at baseline and appraise the safety of aiTBS treatment in these parameters which contain five more sections than the published protocols. To record the change in sensitivity to pain and examine the tolerability of the treatment for these participants, visual analogue scale (VAS) is employed after completing 5 sessions treatment every day.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: active stimulation Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days. |
Device: Active iTBS
MagPro X100
|
| Sham Comparator: Sham stimulation Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days. |
Device: Sham iTBS
MagPro X100
|
Outcome Measures
Primary Outcome Measures
- Changes in the Deliberate Self-Harm Inventory (DSHI) [Baseline, after 5 treatment days, 2 week and 4 week post-treatment]
Range from 0-180, higher score indicates more severe NSSI.
- Changes in Beck Suicidal Scale Inventory (BSI) [Baseline, after 5 treatment days, 2 week and 4 week post-treatment]
Range from 0-100, higher score indicates more severe suicide ideation.
- Changes in number of occurrences of Non-Suicidal Self Injurious ideation Through SITBI-R [Baseline, after 5 treatment days, 2 week and 4 week post-treatment]
The frequency of NSSI thoughts during the latest week
- Changes in likelihood of future Non-Suicidal Self Injury Through SITBI-R [Baseline, after 5 treatment days, 2 week and 4 week post-treatment]
Range from 0-4, higher score indicates more likelihood to conduct NSSI in the future
- Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17) [Baseline, after 5 treatment days, 2 week and 4 week post-treatment]
This will be measured as both a continuous variable (scores on HAMD-17 ) and a categorical one (i.e. the response rates of >50% reduction from baseline HAMD-17 and remission rates defined as HAMD-17 <7).
Secondary Outcome Measures
- Changes in Pittsburgh Sleep Quality Index (PSQI) [Baseline, after 5 treatment days, 2 week and 4 week post-treatment]
Range from 0-21, higher score indicates severe poorer sleep quality
- Changes in Hamilton Anxiety Scale (HAMA) [Baseline, after 5 treatment days, 2 week and 4 week post-treatment]
Range from 0-56, higher score indicates more severe symptoms
- Changes in Young's Mania Scale (YMRS) [Baseline, after 5 treatment days, 2 week and 4 week post-treatment]
Range from 0-60, higher score indicates more severe symptoms
- Changes in Barratt Impulsiveness Scale-11 (BIS-11) [Baseline, after 5 treatment days, 2 week and 4 week post-treatment]
Range from 0-104, higher score indicates higher impulsivity
- Changes in addiction of Non-Suicidal Self Injury through Ottawa self-injury inventory (OSI) [Baseline, after 5 treatment days, 2 week and 4 week post-treatment]
Range from 0-28, higher score indicates higher addiction
- Changes in cerebral blood flow of left DLPFC through Near Infrared Spectroscopy (fNIRS) [Baseline, after 5 treatment days, and 4 week post-treatment]
Measuring the hemoglobin concentration of cerebral cortex during verbal fluency test and emotion recognition test.
- Changes in selective attention through eye-tracking task. [Baseline, after 5 treatment days, and 4 week post-treatment]
Eye-tracking task was performed using the free-viewing paradigm. By presenting images of irritable, threatening, positive, and neutral emotional scenes, the subject's selective attention (total fixation duration, mean fixation count, mean fixation duration) was measured.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Documentation of DSM-5 criteria for current major depressive disorder (MDD) or bipolar disorder (BD) will be required for study entry.
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Ages between 12 and 18 years
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At least 1 caregivers to supervise the patient within 3 month.
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A score of greater than 17 on the HAM-D17.
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Occurrences of self injury behavior consistent with the DSM-5 criteria of NSSI more than 3 times in a month.
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Willingness to participate in the study and sign informed consents
Exclusion Criteria:
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Substance abusers such as psychoactive drugs or alcohol.
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Severe physical disability and unable to complete follow-up.
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Comorbid other major mental illnesses that meet the DSM-5 criteria, such as schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.
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Currently in a manic episode, YMRS>15; rapid-cycling bipolar disorder.
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Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
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Unable to read, understand and complete the assessment or to cooperate with the investigators.
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Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for rTMS.
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A history or family history of epilepsy and other contraindications to TMS.
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Daily use of benzodiazepines, trazodone, theophylline, stimulants such as methylphenidate, anticonvulsants, bupropion, etc.
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Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) within 3 months before baseline.
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Significant anxiety disorder, HAMA ≥ 21 points.
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Other examination abnormalities considered to be inappropriate by investigators.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mental Health Institute of Second Xiangya Hospital,CSU | Changsha | Hunan | China | 410011 |
Sponsors and Collaborators
- Central South University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TMS20220425