Insomnia ChronicNCT06710652
Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline
A study testing rTMS in people with Insomnia Chronic and Subjective Cognitive Decline (SCD), run by Fujian Medical University Union Hospital.
Trial summary
Insomnia is the most common form of sleep disorder, and subjective cognitive decline (SCD) in patients with insomnia may be an ultra-early manifestation of AD. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising tool for the treatment of insomnia by modulating neural excitability and… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Insomnia Chronic, Subjective Cognitive Decline (SCD)
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Aged 30-80 years old; (2) Diagnostic criteria for insomnia: DSM-V and ICSD-3; (3) Subjective cognitive decline. (4) Regular use of non-benzodiazepines for insomnia.
Who cannot join
- (1) Refuse participants; (2) Presence of cognitive dysfunction; (3) Combined with other diseases other than central nervous system non-neurodegenerative diseases; (4) Use drugs that may affect cognition, degree of awakening and sleep quality due to other diseases; (5) Contraindications to rTMS treatment: (6) Severe complications and immune diseases; (7) Inability to cooperate; (8) Pregnancy or lactation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline: a Randomized Controlled Trail
Insomnia is the most common form of sleep disorder, and subjective cognitive decline (SCD) in patients with insomnia may be an ultra-early manifestation of AD. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising tool for the treatment of insomnia by modulating neural excitability and inducing plasticity. However, there is a lack of studies on rTMS treatment of cognitive impairment associated with insomnia. The efficacy and safety of rTMS for cognitive impairment in insomnia patients with SCD will be assessed by a randomized controlled trial.
- Being tested
- rTMS, Sham Comparator
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Stimulation coil Cool-B65 A CO, located right lingual gyrus, stimulation frequency 1Hz, stimulation intensity 80% of motor threshold, number of stimuli 3 pulses/train, train interval 1s, 500 trains in total, 1500 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week.
Sham ComparatorDevice
Stimulation coil Cool-B65 P CO, located right lingual gyrus, stimulation frequency 1Hz, stimulation intensity 80% of motor threshold, number of stimuli 3 pulses/train, train interval 1s, 500 trains in total, 1500 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week.
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | Not described Receives: Device: rTMS |
| sham rTMS | Sham comparator | Not described Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline SCD-Q9 to 2 weeks
9-item Subjective Cognitive Decline Questionnaire (SCD-Q9)
Measured: Baseline vs 2 weeks after treatment
Change from baseline MMSE to 2 weeks
Mini-Mental State Examination (MMSE)
Measured: Baseline vs 2 weeks after treatment
Secondary outcomes (13)
Change from baseline MoCA scores to 2 weeks
Montreal Cognitive Assessment (MoCA)
Measured: Baseline vs 2 weeks after treatment
Change from baseline CDR to 2 weeks
Clinical Dementia Rating (CDR)
Measured: Baseline vs 2 weeks after treatment
Change from baseline RAVLT to 2 weeks
Rey Auditory Verbal Learning Test (RAVLT)
Measured: Baseline vs 2 weeks after treatment
Change from baseline HAMA to 2 weeks
Human Anti-Murine Antibodies (HAMA)
Measured: Baseline vs 2 weeks after treatment
Change from baseline HAMD to 2 weeks
Hamilton Rating Scale for Depression (HAMD)
Measured: Baseline vs 2 weeks after treatment
Change from baseline NPI to 2 weeks
Neuropsychiatric Inventory (NPI)
Measured: Baseline vs 2 weeks after treatment
Change from baseline CDS to 2 weeks
Coding Digit Symbol subtest (CDS)
Measured: Baseline vs 2 weeks after treatment
Change from baseline DDS to 2 weeks
Direct Digit Span subtest (DDS)
Measured: Baseline vs 2 weeks after treatment
Change from baseline inflammatory factors and neuropathological markers to 2 weeks
Aβ, tau, GFAP, α-Synuclein, NFL, VEGF, AQP4, RNA sequencing, pre.Caspase1, cl.Caspase1, pre.IL-1β, cl.IL-1β, IL-18, GSDMD, ASC, NLRP1, Iba-1, GFAP, NeuN, CD86, CD206, iNOS, Arg1, TLR4, TLR2, MyD88, NFκB, tau, p-NFκB, NLRP3, β-actin, ect.
Measured: Baseline vs 2 weeks after treatment
Change from baseline PAF to 2 weeks
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
Measured: Baseline vs 2 weeks after treatment
Change from baseline structural imaging indicators to 2 weeks
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.And NODDI models the dispersion of axonal fibers with the use of an Orientation Dispersion Index (ODI).
Measured: Baseline vs 2 weeks after treatment
Change from baseline adverse events to 2 weeks
Headache, tinnitus, pure tone hearing disorder, ect.
Measured: Baseline vs 2 weeks after treatment
Change from baseline TMS-EEG to 2 weeks
Concurrent transcranial magnetic stimulation and electroencephalography (TMS-EEG)
Measured: Baseline vs 2 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710652
- Sponsor's protocol ID
- rTMS-insomnia
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline: a Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT06710652
- Acronym / sponsor ID
- rTMS-insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Nov 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.
Insomnia is the most common form of sleep disorder, and subjective cognitive decline (SCD) in patients with insomnia may be an ultra-early manifestation of AD. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising tool for the treatment of insomnia by modulating neural excitability and inducing plasticity. However, there is a lack of studies on rTMS treatment of cognitive impairment associated with insomnia. The efficacy and safety of rTMS for cognitive impairment in insomnia patients with SCD will be assessed by a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Device: rTMS |
| sham rTMS | Sham comparator | Device: Sham Comparator |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Aged 30-80 years old; (2) Diagnostic criteria for insomnia: DSM-V and ICSD-3; (3) Subjective cognitive decline. (4) Regular use of non-benzodiazepines for insomnia.
Key exclusion criteria (1 listed)
- (1) Refuse participants; (2) Presence of cognitive dysfunction; (3) Combined with other diseases other than central nervous system non-neurodegenerative diseases; (4) Use drugs that may affect cognition, degree of awakening and sleep quality due to other diseases; (5) Contraindications to rTMS treatment: (6) Severe complications and immune diseases; (7) Inability to cooperate; (8) Pregnancy or lactation.
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 |
|---|---|---|
| rTMSStimulation coil Cool-B65 A CO, located right lingual gyrus, stimulation frequency 1Hz, stimulation intensity 80% of motor threshold, number of stimuli 3 pulses/train, train interval 1s, 500 trains in total, 1500 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week. | Device | rTMS |
| Sham ComparatorStimulation coil Cool-B65 P CO, located right lingual gyrus, stimulation frequency 1Hz, stimulation intensity 80% of motor threshold, number of stimuli 3 pulses/train, train interval 1s, 500 trains in total, 1500 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week. | Device | sham rTMS |
Primary outcome
Change from baseline SCD-Q9 to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
9-item Subjective Cognitive Decline Questionnaire (SCD-Q9)
Change from baseline MMSE to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Mini-Mental State Examination (MMSE)
13 secondary outcomes
Change from baseline MoCA scores to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline CDR to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline RAVLT to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline HAMA to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline HAMD to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline NPI to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline CDS to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline DDS to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline inflammatory factors and neuropathological markers to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline PAF to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline structural imaging indicators to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline adverse events to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Change from baseline TMS-EEG to 2 weeks
Time frame: Baseline vs 2 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Insomnia Chronic and Subjective Cognitive Decline (SCD), run by Fujian Medical University Union Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Pan (0591-86218341, panxd@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline SCD-Q9 to 2 weeks (time frame: Baseline vs 2 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2024.