Stress, PsychologicalNCT06653959
Precision Transcranial Magnetic Stimulation for Patients With Post-stress Sleep Disorders
A study testing active Transcranial Magnetic Stimulation in people with Stress, Psychological and Sleep Initiation and Maintenance Disorders, run by Xijing Hospital at 1 site in China.
Trial summary
This is a randomized, double-blind controlled study that recruited patients with insomnia problems after suffering a stressful event to undergo individualized transcranial magnetic stimulation Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stress, Psychological, Sleep Initiation and Maintenance Disorders, Transcranial Magnetic Stimulation
- What is being tested?
- active Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be between the ages of 18 and 60 (both 18 and 60) and of any gender;
- Experienced a severe traumatic event;
- Stanford Acute Stress Reaction Questionnaire (SASRQ) ≥40 points;
- PSQI > 7 points;
- Good compliance and willingness to undergo this therapy.
Who cannot join
- Sleep disorders that can be explained by a primary illness;
- Concurrent psychotherapy;
- Those with contraindications to magnetic resonance examination and transcranial magnetic stimulation therapy;
- Combined with serious cardiovascular, hepatic, renal, digestive, hematopoietic system and other primary diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital
Xi'an, Shaanxi, 710000
zhao, PhD, 18792536506, zhangyc_2022@126.com
About this study
Official title: Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation Based on vlPFC-VTA Individualized Functional Connectivity Localization for the Treatment of Post-stress Sleep Disorders
This is a randomized, double-blind controlled study that recruited patients with insomnia problems after suffering a stressful event to undergo individualized transcranial magnetic stimulation
Read the detailed description
This is a randomized, double-blind controlled study that will recruit patients who have experienced a stressful event and currently exhibit severe sleep problems for transcranial magnetic stimulation. They will be randomly assigned to the trial and control groups and will receive 5 consecutive days of continuous theta-wave stimulation, and before and after the treatment they will be assessed on clinical scales and undergo magnetic resonance examinations as well as sleep monitoring.
- Conditions
- Stress, Psychological, Sleep Initiation and Maintenance Disorders, Transcranial Magnetic Stimulation
- Being tested
- active Transcranial Magnetic Stimulation, sham Transcranial Magnetic Stimulation
- Medical subject headings
- Stress, Psychological, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active Transcranial Magnetic StimulationDevice
Based on each individual's MRI data, individualized stimulation targets will be found, and then this will be used for stimulation for 5 consecutive days.
sham Transcranial Magnetic StimulationDevice
Based on each individual's MRI data, individualized stimulation targets will be found, and then this will be used for sham stimulation for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| active Transcranial Magnetic Stimulation | Active comparator | The most relevant site of functional connectivity between vlPFC-VTA will be targeted for continuous theta burst stimulation Receives: Device: active Transcranial Magnetic Stimulation |
| sham Transcranial Magnetic Stimulation | Placebo comparator | The most relevant site of functional connectivity between vlPFC-VTA will be targeted for sham continuous theta burst stimulation Receives: Device: sham Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to post-treatment
The Pittsburgh Sleep Quality Index, compiled in 1989 by Dr. Buysse, a psychiatrist at the University of Pittsburgh, and others. It is suitable for patients with sleep disorders to evaluate the quality of their sleep, as well as for the general population to assess the quality of their sleep. The scale consists of 9 questions, of which the first 4 are fill-in-the-blanks and the last 5 are multiple-choice (question 5 contains 10 sub-questions) Change = (treatment day 5 Score -Baseline Score).
Measured: Baseline and treatment day 5
Secondary outcomes (8)
Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to treatment day 5
Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5（PCL-5） is a validated, self-reported instrument assessing PTSD symptom severity over the past week or month period .Possible scores range from 0 to 80 .
Change = (treatment day 5 Score -Baseline Score).
Measured: Baseline and treatment day 5
Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to treatment day 5
The Stanford Acute Stress Reaction Questionnaire (SASRQ) is a commonly used international instrument for assessing acute stress disorders. It consists of 5 dimensions, including alertness, dissociation, avoidance, re-experiencing, and impairment of social functioning, with a total of 30 items, ranging from "not experiencing" to "always experiencing". A total of 30 items, ranging from "no experience" to "always experience", were assigned a score of 0 to 5, with a total score of 0 to 150. The higher the total score, the more severe the acute stress disorder, with a score of ≥40 suggesting a moderate likelihood of acute stress disorder.
Change = (treatment day 5 Score -Baseline Score).
Measured: Baseline and treatment day 5
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 5 Score
Hamilton Depression Scale（HAMD-17） is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.
Change = (treatment day 5 Score -Baseline Score).
Measured: Baseline and treatment day 5
Change in Hamilton Anxiety Scale scores from baseline to treatment day 5 Score
Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.
Change = (treatment day 5 Score -Baseline Score).
Measured: Baseline and treatment day 5
Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to 28 days after the end of treatment
Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5（PCL-5） is a validated, self-reported instrument assessing PTSD symptom severity over the past week or month period .Possible scores range from 0 to 80 .
Change = (28 days after the end of treatment Score -Baseline Score).
Measured: Baseline and 28 days after the end of treatment
Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to 28 days after the end of treatment
The Stanford Acute Stress Reaction Questionnaire (SASRQ) is a commonly used international instrument for assessing acute stress disorders. It consists of 5 dimensions, including alertness, dissociation, avoidance, re-experiencing, and impairment of social functioning, with a total of 30 items, ranging from "not experiencing" to "always experiencing". A total of 30 items, ranging from "no experience" to "always experience", were assigned a score of 0 to 5, with a total score of 0 to 150. The higher the total score, the more severe the acute stress disorder, with a score of ≥40 suggesting a moderate likelihood of acute stress disorder.
Change = (28 days after the end of treatment Score -Baseline Score).
Measured: Baseline and 28 days after the end of treatment
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment
Hamilton Depression Scale（HAMD-17） is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.
Change = (28 days after the end of treatment Score -Baseline Score).
Measured: Baseline and 28 days after the end of treatment
Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment
Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.
Measured: Baseline and 28 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Cai, PhD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653959
- Sponsor's protocol ID
- KY20242082
- Status last verified
- Apr 2024
- First submitted
- 9 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cai M, Zhu Y, Shanley MR, Morel C, Ku SM, Zhang H, Shen Y, Friedman AK, Han MH. HCN channel inhibitor induces ketamine-like rapid and sustained antidepressant effects in chronic social defeat stress model. Neurobiol Stress. 2023 Aug 19;26:100565. doi: 10.1016/j.ynstr.2023.100565. eCollection 2023 Sep.
PubMed 37664876Luo YJ, Li YD, Wang L, Yang SR, Yuan XS, Wang J, Cherasse Y, Lazarus M, Chen JF, Qu WM, Huang ZL. Nucleus accumbens controls wakefulness by a subpopulation of neurons expressing dopamine D1 receptors. Nat Commun. 2018 Apr 20;9(1):1576. doi: 10.1038/s41467-018-03889-3.
PubMed 29679009Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group; Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7.
PubMed 25192980Blumberger DM, Maller JJ, Thomson L, Mulsant BH, Rajji TK, Maher M, Brown PE, Downar J, Vila-Rodriguez F, Fitzgerald PB, Daskalakis ZJ. Unilateral and bilateral MRI-targeted repetitive transcranial magnetic stimulation for treatment-resistant depression: a randomized controlled study. J Psychiatry Neurosci. 2016 Jun;41(4):E58-66. doi: 10.1503/jpn.150265.
PubMed 27269205
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation Based on vlPFC-VTA Individualized Functional Connectivity Localization for the Treatment of Post-stress Sleep Disorders
- ClinicalTrials.gov ID
- NCT06653959
- Acronym / sponsor ID
- KY20242082
- Conditions
- Stress, Psychological, Sleep Initiation and Maintenance Disorders, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind controlled study that recruited patients with insomnia problems after suffering a stressful event to undergo individualized transcranial magnetic stimulation
Detailed description
This is a randomized, double-blind controlled study that will recruit patients who have experienced a stressful event and currently exhibit severe sleep problems for transcranial magnetic stimulation. They will be randomly assigned to the trial and control groups and will receive 5 consecutive days of continuous theta-wave stimulation, and before and after the treatment they will be assessed on clinical scales and undergo magnetic resonance examinations as well as sleep monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active Transcranial Magnetic Stimulation | Active comparator | Device: active Transcranial Magnetic StimulationThe most relevant site of functional connectivity between vlPFC-VTA will be targeted for continuous theta burst stimulation |
| sham Transcranial Magnetic Stimulation | Placebo comparator | Device: sham Transcranial Magnetic StimulationThe most relevant site of functional connectivity between vlPFC-VTA will be targeted for sham continuous theta burst stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be between the ages of 18 and 60 (both 18 and 60) and of any gender;
- Experienced a severe traumatic event;
- Stanford Acute Stress Reaction Questionnaire (SASRQ) ≥40 points;
- PSQI > 7 points;
- Good compliance and willingness to undergo this therapy.
Key exclusion criteria (4 listed)
- Sleep disorders that can be explained by a primary illness;
- Concurrent psychotherapy;
- Those with contraindications to magnetic resonance examination and transcranial magnetic stimulation therapy;
- Combined with serious cardiovascular, hepatic, renal, digestive, hematopoietic system and other primary diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active Transcranial Magnetic StimulationBased on each individual's MRI data, individualized stimulation targets will be found, and then this will be used for stimulation for 5 consecutive days. | Device | active Transcranial Magnetic Stimulation |
| sham Transcranial Magnetic StimulationBased on each individual's MRI data, individualized stimulation targets will be found, and then this will be used for sham stimulation for 5 consecutive days. | Device | sham Transcranial Magnetic Stimulation |
Primary outcome
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to post-treatment
Time frame: Baseline and treatment day 5
The Pittsburgh Sleep Quality Index, compiled in 1989 by Dr. Buysse, a psychiatrist at the University of Pittsburgh, and others. It is suitable for patients with sleep disorders to evaluate the quality of their sleep, as well as for the general population to assess the quality of their sleep. The scale consists of 9 questions, of which the first 4 are fill-in-the-blanks and the last 5 are multiple-choice (question 5 contains 10 sub-questions) Change = (treatment day 5 Score -Baseline Score).
8 secondary outcomes
Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to treatment day 5
Time frame: Baseline and treatment day 5
Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to treatment day 5
Time frame: Baseline and treatment day 5
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 5 Score
Time frame: Baseline and treatment day 5
Change in Hamilton Anxiety Scale scores from baseline to treatment day 5 Score
Time frame: Baseline and treatment day 5
Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to 28 days after the end of treatment
Time frame: Baseline and 28 days after the end of treatment
Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to 28 days after the end of treatment
Time frame: Baseline and 28 days after the end of treatment
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment
Time frame: Baseline and 28 days after the end of treatment
Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment
Time frame: Baseline and 28 days after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Background: PubMed 37664876Cai M, Zhu Y, Shanley MR, Morel C, Ku SM, Zhang H, Shen Y, Friedman AK, Han MH. HCN channel inhibitor induces ketamine-like rapid and sustained antidepressant effects in chronic social defeat stress model. Neurobiol Stress. 2023 Aug 19;26:100565. doi: 10.1016/j.ynstr.2023.100565. eCollection 2023 Sep.
- Background: PubMed 29679009Luo YJ, Li YD, Wang L, Yang SR, Yuan XS, Wang J, Cherasse Y, Lazarus M, Chen JF, Qu WM, Huang ZL. Nucleus accumbens controls wakefulness by a subpopulation of neurons expressing dopamine D1 receptors. Nat Commun. 2018 Apr 20;9(1):1576. doi: 10.1038/s41467-018-03889-3.
- Background: PubMed 25192980Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group; Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7.
- Background: PubMed 27269205Blumberger DM, Maller JJ, Thomson L, Mulsant BH, Rajji TK, Maher M, Brown PE, Downar J, Vila-Rodriguez F, Fitzgerald PB, Daskalakis ZJ. Unilateral and bilateral MRI-targeted repetitive transcranial magnetic stimulation for treatment-resistant depression: a randomized controlled study. J Psychiatry Neurosci. 2016 Jun;41(4):E58-66. doi: 10.1503/jpn.150265.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Cai, PhD principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active Transcranial Magnetic Stimulation in people with Stress, Psychological and Sleep Initiation and Maintenance Disorders, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yaochi Zhang (18294037117, a18294037117@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to post-treatment (time frame: Baseline and treatment day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06653959, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.