Benign Brain TumorNCT05518942
Effects of SMR Neurofeedback on Insomnia in Patients With Benign Brain Tumors
A study testing sensorimotor rhythm neurofeedback training in people with Benign Brain Tumor and Neurofeedback, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Insomnia is the most common sleep disorder in patients with primary brain tumors. In the past, 21.5% to 59.2% of patients with primary brain tumors suffer from insomnia symptoms. In addition to hypnotics, nonpharmacological interventions for insomnia in patients with brain tumors are still lacking. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Benign Brain Tumor, Neurofeedback, Insomnia
- What is being tested?
- sensorimotor rhythm neurofeedback training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Oct 2022to 19 Apr 2023
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed as primary benign brain tumors such as: meningioma, schwannoma, pituitary tumor, craniopharyngioma according to the results of pathological tissue sections and has completed treatment such as : Surgery, radiation therapy, etc. for at least 7 days.
- Aged from 20 to 65 years old and conscious, able to communicate in Mandarin and Taiwanese.
- Cognitive ability sufficient to complete the questionnaire.
- Complaints of insomnia and ISI score ≥ 8
Who cannot join
- Long-term shift workers one month before the included study.
- Pregnant women.
- Jet lag workers, such as airline workers.
- Vision, hearing or motor dysfunction is severe enough to affect the participating researcher.
- Preoperative diagnosis of insomnia or long-term use of sleep aids or psychiatric drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Sensorimotor Rhythm Neurofeedback on Insomnia in Patients With Benign Brain Tumors Underwent Surgery
Insomnia is the most common sleep disorder in patients with primary brain tumors. In the past, 21.5% to 59.2% of patients with primary brain tumors suffer from insomnia symptoms. In addition to hypnotics, nonpharmacological interventions for insomnia in patients with brain tumors are still lacking. When using hypnotics may cause daytime sleepiness, cognitive impairment, and increase the risk of cancer, seeking an effective intervention is of clinical importance. Sensorimotor rhythm neurofeedback therapy has been shown to improve insomnia in different populations. However, its effect on insomnia has not been explored in patients with brain tumors. We, therefore, aim to investigate the feasibility and effect of sensorimotor rhythm neurofeedback in improving insomnia in patients with benign brain tumors after surgery and to examine the correlation between the degree of insomnia improvement and quality of life changes after receiving sensorimotor rhythm neurofeedback.
Read the detailed description
Brain tumors are mainly divided into primary and metastatic, and are further divided into benign and malignant according to the pathological type. Among them, meningioma and pituitary tumor are the top two most common primary benign brain tumors, accounting for 36.1% respectively. -54.5% and 10-15%, while the most malignant glioblastoma accounts for 45-49.1% of primary malignant brain tumors. Among them, glioblastomas are more common in men and meningiomas are more common in women.
Insomnia is the most common sleep disorder in patients with primary brain tumors. Insomnia refers to difficulty falling asleep, staying awake and unable to fall asleep while sleeping, frequently waking up during sleep period or shortening sleep time, resulting in still feeling tired after getting up and affecting daily life functions. In the past, in terms of the prevalence of insomnia, primary brain 21.5%~59.2% of patients with tumor had insomnia symptoms, and if subdivided into benign, 46.8% of patients with primary benign brain tumor.
According to the results of the study, patients with primary brain tumors still have widespread and persistent insomnia problems after treatment, and even up to one year after surgery, there are still studies showing insomnia problems. Savard et al (2011) reported that insomnia is also a cancer A common and persistent problem among patients, the attack rate of insomnia generally decreased over time, but remained prevalent (36%) even at the end of 18 months. However, in real life, although insomnia has a high attack rate and a high burden on the family, and even affects the overall quality of life of patients, it is often not valued and treated.
Neurofeedback (NFB), also known as brain wave training, is a method to help subjects consciously control their brain waves. In order to reflect the state of brain activity, the software analyzes the measured brain waves and provides feedback signals to teach individuals to self-regulate brain waves. After repeated training, the target brain waves can be generated. When the threshold is reached, it will give visual and auditory feedback. Neurofeedback has been used clinically in many diseases and healthy individuals that cannot be effectively treated with drugs, such as insomnia, ADHD, epilepsy, fibromyalgia, depression, anxiety, pain, learning and memory, etc. For insomnia, the use of neurofeedback therapy can help people who usually take an hour or so to fall asleep fall asleep faster.
According to Lambert-Beaudet et al. (2021) reviewing the latest research on the use of neurofeedback in the treatment of insomnia, the enhancement of sensorimotor rhythm neurofeedback to improve insomnia was the most included and confirmed to improve insomnia. And multiple studies have confirmed that sensorimotor rhythm neurofeedback enhancement training can lead to increased sleep spindle density, decreased sleep onset latency, increased total sleep time, and decreased wake-up after falling asleep. Therefore, sensorimotor rhythm neurofeedback enhancement training can be an effective method for non-drug intervention in the treatment of insomnia. Given that the effects of sensorimotor rhythm neurofeedback training on insomnia have not been studied in patients with benign brain tumors after surgery, further studies in this group are warranted.
- Conditions
- Benign Brain Tumor, Neurofeedback, Insomnia
- Being tested
- sensorimotor rhythm neurofeedback training
- Medical subject headings
- Brain Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensorimotor rhythm neurofeedback trainingBehavioural
In this study, baseline brain waves will be recorded for 5 minutes before each treatment, and the average value of SMR waves was used as the basis for setting the treatment threshold for the week. During the treatment, the subjects are arranged to sit in front of a computer screen with a game or animation playing. The individual focuses on the games or animations on the screen. The software will analyze the brain wave signals from the brain and convert them into visual and auditory feedback on the computer screen. Clients can learn to control brain activity and give visual and auditory feedback when a set threshold is reached
| Study group | Role | What they receive |
|---|---|---|
| sensorimotor rhythm neurofeedback training | Experimental | Sensory motor rhythm neurofeedback: The subjects will perform 60 minutes per week for 10 weeks, with a total training time of 600 minutes. The intervention in this trial lasts for 10 weeks (1 time/week), with the goal of improving sensory motor rhythm. Since this training uses visual and auditory feedback, if patients are assigned to this group, they will be ask to wear an EEG cap with 19 electrodes. They can take a relaxed sitting posture and choose animations (e.g., puzzles, mazes, and other feedback content), and then focus on computer screen animation for training, each training time is approximately 60 minutes. Receives: Behavioral: sensorimotor rhythm neurofeedback training |
| control group | No intervention | Patient should maintain their usual activity and treatment. Research assistants will weekly contact them to confirm their compliance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Insomnia Severity
The ISI consists of seven items, and each item can be rated from 0 to 4, resulting in total score ranging from 0 to 28, with higher scores indicating greater insomnia severity. A cutoff score of > 7 is used to diagnose subthreshold insomnia.
Measured: at baseline and the 10th week after Intervention finished
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.
Measured: at baseline and the 10th week after Intervention finished
Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.
Measured: at baseline and the 10th week after Intervention finished
Changes in Sleep parameters from sleep logs: total sleep time(TST)
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
Measured: at baseline and the 10th week after Intervention finished
Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.
Measured: at baseline and the 10th week after Intervention finished
Secondary outcomes (4)
changes in quality of life
The M.D. Anderson Syndrome Inventory-Taiwan Form (MDASI-Taiwan Form) is mainly used to assess the severity of various cancer symptoms in cancer patients due to cancer disease itself and various cancer treatments. The item, divided into two parts, the first part is the severity of cancer symptoms (symptom intensity): 0 points means no symptoms, 10 points means the most severe degree you can imagine, 1-3 points are mild, 4-6 points are mild Moderate, a score of 7 or more is severe; Part II: Severity of cancer symptoms that interfere with the functioning of life activities (life interference intensity): 0 means no interference, 10 means complete interference, and 1-3 means mild , 4 - 6 as moderate, 7 or more as severe.
Measured: at baseline and the 10th week after Intervention finished
Changes in Depression
Depression will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of depression. The total score should be multiplied by 2 range from 0-42, if score>9 is associated with depression. The higher score means more severe depression
Measured: at baseline and the 10th week after Intervention finished
Changes in Anxiety
Anxiety will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of anxiety. The total score should be multiplied by 2 range from 0-42, if score>7 is associated with anxiety. The higher score means more severe anxiety.
Measured: at baseline and the 10th week after Intervention finished
Changes in Stress
Stress will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of stress. The total score should be multiplied by 2 range from 0-42, if score>14 is associated with anxiety. The higher score means more severe stress
Measured: at baseline and the 10th week after Intervention finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start26 Oct 2022
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Why it stopped: Difficulty recruiting cases due to the epidemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Brain TumorStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518942
- Sponsor's protocol ID
- 202200998B0A3
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2022
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sensorimotor Rhythm Neurofeedback on Insomnia in Patients With Benign Brain Tumors Underwent Surgery
- ClinicalTrials.gov ID
- NCT05518942
- Acronym / sponsor ID
- 202200998B0A3
- Conditions
- Benign Brain Tumor, Neurofeedback, Insomnia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting cases due to the epidemic
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 29 Aug 2022 (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 sleep disorder in patients with primary brain tumors. In the past, 21.5% to 59.2% of patients with primary brain tumors suffer from insomnia symptoms. In addition to hypnotics, nonpharmacological interventions for insomnia in patients with brain tumors are still lacking. When using hypnotics may cause daytime sleepiness, cognitive impairment, and increase the risk of cancer, seeking an effective intervention is of clinical importance. Sensorimotor rhythm neurofeedback therapy has been shown to improve insomnia in different populations. However, its effect on insomnia has not been explored in patients with brain tumors. We, therefore, aim to investigate the feasibility and effect of sensorimotor rhythm neurofeedback in improving insomnia in patients with benign brain tumors after surgery and to examine the correlation between the degree of insomnia improvement and quality of life changes after receiving sensorimotor rhythm neurofeedback.
Detailed description
Brain tumors are mainly divided into primary and metastatic, and are further divided into benign and malignant according to the pathological type. Among them, meningioma and pituitary tumor are the top two most common primary benign brain tumors, accounting for 36.1% respectively. -54.5% and 10-15%, while the most malignant glioblastoma accounts for 45-49.1% of primary malignant brain tumors. Among them, glioblastomas are more common in men and meningiomas are more common in women.
Insomnia is the most common sleep disorder in patients with primary brain tumors. Insomnia refers to difficulty falling asleep, staying awake and unable to fall asleep while sleeping, frequently waking up during sleep period or shortening sleep time, resulting in still feeling tired after getting up and affecting daily life functions. In the past, in terms of the prevalence of insomnia, primary brain 21.5%~59.2% of patients with tumor had insomnia symptoms, and if subdivided into benign, 46.8% of patients with primary benign brain tumor.
According to the results of the study, patients with primary brain tumors still have widespread and persistent insomnia problems after treatment, and even up to one year after surgery, there are still studies showing insomnia problems. Savard et al (2011) reported that insomnia is also a cancer A common and persistent problem among patients, the attack rate of insomnia generally decreased over time, but remained prevalent (36%) even at the end of 18 months. However, in real life, although insomnia has a high attack rate and a high burden on the family, and even affects the overall quality of life of patients, it is often not valued and treated.
Neurofeedback (NFB), also known as brain wave training, is a method to help subjects consciously control their brain waves. In order to reflect the state of brain activity, the software analyzes the measured brain waves and provides feedback signals to teach individuals to self-regulate brain waves. After repeated training, the target brain waves can be generated. When the threshold is reached, it will give visual and auditory feedback. Neurofeedback has been used clinically in many diseases and healthy individuals that cannot be effectively treated with drugs, such as insomnia, ADHD, epilepsy, fibromyalgia, depression, anxiety, pain, learning and memory, etc. For insomnia, the use of neurofeedback therapy can help people who usually take an hour or so to fall asleep fall asleep faster.
According to Lambert-Beaudet et al. (2021) reviewing the latest research on the use of neurofeedback in the treatment of insomnia, the enhancement of sensorimotor rhythm neurofeedback to improve insomnia was the most included and confirmed to improve insomnia. And multiple studies have confirmed that sensorimotor rhythm neurofeedback enhancement training can lead to increased sleep spindle density, decreased sleep onset latency, increased total sleep time, and decreased wake-up after falling asleep. Therefore, sensorimotor rhythm neurofeedback enhancement training can be an effective method for non-drug intervention in the treatment of insomnia. Given that the effects of sensorimotor rhythm neurofeedback training on insomnia have not been studied in patients with benign brain tumors after surgery, further studies in this group are warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sensorimotor rhythm neurofeedback training | Experimental | Behavioral: sensorimotor rhythm neurofeedback trainingSensory motor rhythm neurofeedback: The subjects will perform 60 minutes per week for 10 weeks, with a total training time of 600 minutes. The intervention in this trial lasts for 10 weeks (1 time/week), with the goal of improving sensory motor rhythm. Since this training uses visual and auditory feedback, if patients are assigned to this group, they will be ask to wear an EEG cap with 19 electrodes. They can take a relaxed sitting posture and choose animations (e.g., puzzles, mazes, and other feedback content), and then focus on computer screen animation for training, each training time is approximately 60 minutes. |
| control group | No intervention | –Patient should maintain their usual activity and treatment. Research assistants will weekly contact them to confirm their compliance. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed as primary benign brain tumors such as: meningioma, schwannoma, pituitary tumor, craniopharyngioma according to the results of pathological tissue sections and has completed treatment such as : Surgery, radiation therapy, etc. for at least 7 days.
- Aged from 20 to 65 years old and conscious, able to communicate in Mandarin and Taiwanese.
- Cognitive ability sufficient to complete the questionnaire.
- Complaints of insomnia and ISI score ≥ 8
Key exclusion criteria (5 listed)
- Long-term shift workers one month before the included study.
- Pregnant women.
- Jet lag workers, such as airline workers.
- Vision, hearing or motor dysfunction is severe enough to affect the participating researcher.
- Preoperative diagnosis of insomnia or long-term use of sleep aids or psychiatric drugs.
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 |
|---|---|---|
| sensorimotor rhythm neurofeedback trainingIn this study, baseline brain waves will be recorded for 5 minutes before each treatment, and the average value of SMR waves was used as the basis for setting the treatment threshold for the week. During the treatment, the subjects are arranged to sit in front of a computer screen with a game or animation playing. The individual focuses on the games or animations on the screen. The software will analyze the brain wave signals from the brain and convert them into visual and auditory feedback on the computer screen. Clients can learn to control brain activity and give visual and auditory feedback when a set threshold is reached | Behavioural | sensorimotor rhythm neurofeedback training |
Primary outcome
Changes in Insomnia Severity
Time frame: at baseline and the 10th week after Intervention finished
The ISI consists of seven items, and each item can be rated from 0 to 4, resulting in total score ranging from 0 to 28, with higher scores indicating greater insomnia severity. A cutoff score of > 7 is used to diagnose subthreshold insomnia.
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
Time frame: at baseline and the 10th week after Intervention finished
Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
Time frame: at baseline and the 10th week after Intervention finished
Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: total sleep time(TST)
Time frame: at baseline and the 10th week after Intervention finished
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
Time frame: at baseline and the 10th week after Intervention finished
Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.
4 secondary outcomes
changes in quality of life
Time frame: at baseline and the 10th week after Intervention finished
Changes in Depression
Time frame: at baseline and the 10th week after Intervention finished
Changes in Anxiety
Time frame: at baseline and the 10th week after Intervention finished
Changes in Stress
Time frame: at baseline and the 10th week after Intervention finished
Results and safety
The study was stopped early (reason given: Difficulty recruiting cases due to the epidemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
Related trials for Benign Brain Tumor
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes
Stroke, Brain Injuries, Traumatic
RecruitingEarly Phase 1
Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
Meningioma, Glioblastoma
Not yet recruiting
A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas
Glioma, Glioma Intracranial
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensorimotor rhythm neurofeedback training in people with Benign Brain Tumor and Neurofeedback, run by Taipei Medical University at 1 site in Taiwan.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 22 Apr 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 Taiwan. 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. 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?
The study was stopped early (reason given: Difficulty recruiting cases due to the epidemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Insomnia Severity (time frame: at baseline and the 10th week after Intervention finished). The study lists 5 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 22 Apr 2024.