search
Back to results

A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-Definition transcranial electrical stimulation
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Transcranial electrical stimulation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 18 and 50 years old;

    • The patients were diagnosed as insomnia according to the diagnostic and Statistical Manual of Mental Disorders (DSM-5) and Mini-International Neuropsychiatric Interview (M.I.N.I.) .

      • No psychiatric drugs were taken within 8 weeks before enrollment; ④ Junior high school education or above.

Exclusion Criteria:

  • Past or current DSM-5 diagnoses other than insomnia, anxiety disorder and depressive disorder

    • Severe anxiety or depression (HAMD-17 > 23 points or HAMA > 30 points)

      • Patients with obstructive sleep apnea syndrome;

        • Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.

          • Previous history of neurological diseases (such as epilepsy, cerebrovascular accidents, etc.) or brain trauma, brain surgery; ⑥Have received ECT, rTMS, tES, or cognitive behavioral therapy for insomnia; ⑦Any current significant medical condition. ⑧Women who are pregnant or planning to become pregnant recently

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tES treatment

Arm Description

The stimulation type is cathode direct current stimulation and alternating current stimulation. The maximum stimulation current of a single channel is not more than 3mA. The frequency of electrical stimulation was 0-10Hz; DLPFC was preferentially selected for electrical stimulation, and other candidate brain regions were: orbitofrontal cortex premotor cortex, motor cortex, sensorimotor cortex, auditory cortex, posterior parietal cortex, and cerebellar cortex. The brain state changes caused by each stimulus parameter combination were compared with sleep state to determine the optimal stimulus parameters. Each cycle of stimulation was 2 weeks, once a night on weekdays, a total of 10 times

Outcomes

Primary Outcome Measures

Change in sleep latency
Sleep latency is the time it takes a person to fall asleep after turning the lights out. This parameter can be measured by the sleep diary and the Sleep bracelet.
Change in sleep time
The total amount of time the participants actually fall asleep to wake up. This parameter can be measured by the sleep diary and the Sleep bracelet.
Change in sleep efficiency
Sleep efficiency (SE) is the ratio between the time a person spends asleep, and the total time dedicated to sleep (i.e. both sleeping and attempting to fall asleep or fall back asleep). It is given as a percentage. SE of 80% or more is considered normal/healthy with most young healthy adults displaying SE above 90%.This parameter can be calculated according to the sleep diary.
Change in Pittsburgh Sleep Quality Index(PSQI)
Treatment effectiveness was defined as 50% reduction of PSQI after treatment from baseline, clinical remission was defined as PSQI score less than 5, reduction rate = (pre-treatment score - post-treatment score)/pre-treatment score x100%, and total effective cases/total cases ×100% was the total effective rate

Secondary Outcome Measures

Change in Insomnia Severity Index,ISI
The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is increasingly used as a metric of treatment response in clinical research.
Change in Epworth Sleepiness Scale, ESS
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities.
Change in Ford Insomnia Response to Stress Test, FIRST
It is a nine-item self-report instrument that tests the likelihood that an individual will get sleep disturbances following various stressful events.
Change in Beck Depression Inventory, BDI
It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.
Change in Beck Anxiety Inventory, BAI
It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.
Change in Side-effect questionnaire
It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.

Full Information

First Posted
June 28, 2022
Last Updated
September 7, 2022
Sponsor
Shanghai Mental Health Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05445999
Brief Title
A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia
Official Title
A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.
Detailed Description
Twelve insomnia patients in Shanghai Mental Health Center who met the inclusion criteria will be recruited for transcranial electrical stimulation intervention. According to the patients' magnetic resonance structure and high density eeg parameters, personalized modeling was carried out to determine the specific stimulus parameter scheme.The stimulation will be performed for 2 weeks, once a night on weekdays, 10 times in total, and each stimulation will last for 20 minutes. Sleep rhythms will be recorded using a wearable device. Symptom assessment, magnetic resonance and high-density eeg data will be taken after the stimulation, and again 1 week after the stimulation.If the treatment is effective or clinical remission is achieved, the next cycle of stimulation will not be performed; If the treatment does not work, the patients choose to end the study or conduct modeling again to adjust the parameters and continue the next cycle of stimulation according to their wishes. For patients who choose to continue stimulation, the stimulation time of each cycle is still 2 weeks, once every night on weekdays, 10 times in total for each cycle, lasting 20 minutes each time. Each patient received up to four cycles of stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Transcranial electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tES treatment
Arm Type
Experimental
Arm Description
The stimulation type is cathode direct current stimulation and alternating current stimulation. The maximum stimulation current of a single channel is not more than 3mA. The frequency of electrical stimulation was 0-10Hz; DLPFC was preferentially selected for electrical stimulation, and other candidate brain regions were: orbitofrontal cortex premotor cortex, motor cortex, sensorimotor cortex, auditory cortex, posterior parietal cortex, and cerebellar cortex. The brain state changes caused by each stimulus parameter combination were compared with sleep state to determine the optimal stimulus parameters. Each cycle of stimulation was 2 weeks, once a night on weekdays, a total of 10 times
Intervention Type
Device
Intervention Name(s)
High-Definition transcranial electrical stimulation
Intervention Description
According to the results of structural phase magnetic resonance and electroencephalogram, four optimal stimulation parameters will be determined.Transcranial electrical stimulation devices (Sorterix)will be used for intervention.In each cycle, the stimulation will be performed every night during weekdays,a total of 10 times.A maximum of four cycles of intervention will be performed for each patient, depending on the efficacy and the their wishes.
Primary Outcome Measure Information:
Title
Change in sleep latency
Description
Sleep latency is the time it takes a person to fall asleep after turning the lights out. This parameter can be measured by the sleep diary and the Sleep bracelet.
Time Frame
Up to 3 months
Title
Change in sleep time
Description
The total amount of time the participants actually fall asleep to wake up. This parameter can be measured by the sleep diary and the Sleep bracelet.
Time Frame
Up to 3 months
Title
Change in sleep efficiency
Description
Sleep efficiency (SE) is the ratio between the time a person spends asleep, and the total time dedicated to sleep (i.e. both sleeping and attempting to fall asleep or fall back asleep). It is given as a percentage. SE of 80% or more is considered normal/healthy with most young healthy adults displaying SE above 90%.This parameter can be calculated according to the sleep diary.
Time Frame
Up to 3 months
Title
Change in Pittsburgh Sleep Quality Index(PSQI)
Description
Treatment effectiveness was defined as 50% reduction of PSQI after treatment from baseline, clinical remission was defined as PSQI score less than 5, reduction rate = (pre-treatment score - post-treatment score)/pre-treatment score x100%, and total effective cases/total cases ×100% was the total effective rate
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Change in Insomnia Severity Index,ISI
Description
The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is increasingly used as a metric of treatment response in clinical research.
Time Frame
Up to 3 months
Title
Change in Epworth Sleepiness Scale, ESS
Description
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities.
Time Frame
Up to 3 months
Title
Change in Ford Insomnia Response to Stress Test, FIRST
Description
It is a nine-item self-report instrument that tests the likelihood that an individual will get sleep disturbances following various stressful events.
Time Frame
Up to 3 months
Title
Change in Beck Depression Inventory, BDI
Description
It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.
Time Frame
Up to 3 months
Title
Change in Beck Anxiety Inventory, BAI
Description
It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.
Time Frame
Up to 3 months
Title
Change in Side-effect questionnaire
Description
It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 18 and 50 years old; The patients were diagnosed as insomnia according to the diagnostic and Statistical Manual of Mental Disorders (DSM-5) and Mini-International Neuropsychiatric Interview (M.I.N.I.) . No psychiatric drugs were taken within 8 weeks before enrollment; ④ Junior high school education or above. Exclusion Criteria: Past or current DSM-5 diagnoses other than insomnia, anxiety disorder and depressive disorder Severe anxiety or depression (HAMD-17 > 23 points or HAMA > 30 points) Patients with obstructive sleep apnea syndrome; Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body. Previous history of neurological diseases (such as epilepsy, cerebrovascular accidents, etc.) or brain trauma, brain surgery; ⑥Have received ECT, rTMS, tES, or cognitive behavioral therapy for insomnia; ⑦Any current significant medical condition. ⑧Women who are pregnant or planning to become pregnant recently
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Wang
Phone
+86 021-34773516
Email
wangzhen@smhc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Wang
Phone
+86 021-64387250
Email
wangzhen@smhc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Wang, PhD,MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200234
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Wang
Phone
+86 34773516
Email
wangzhen@smhc.org.cn

12. IPD Sharing Statement

Learn more about this trial

A Preliminary Study of Model-driven Individualized Transcranial Electrical Stimulation for Insomnia

We'll reach out to this number within 24 hrs