Mild Cognitive Impairment (MCI)NCT06687161
Treating Insomnia in Mild Cognitive Impairment
A study testing Transcranial Magnetic Stimulation (TMS) therapy and Cognitive behavioral therapy for insomnia (CBT-I) in people with Mild Cognitive Impairment (MCI) and Insomnia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Insomnia
- What is being tested?
- Transcranial Magnetic Stimulation (TMS) therapy and Cognitive behavioral therapy for insomnia (CBT-I)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 30 Jun 2028
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 years or older
- Speak and read English
- Clinical diagnosis of MCI or Subjective Cognitive Impairment (SCI)-a perceived gradual worsening in cognitive ability relative to one's younger self, or peer group-reported by either the participant or informant
- Reported insomnia symptoms (sleep-onset and/or sleep maintenance) that cause significant distress or impairment in social, occupational, or other areas of functioning over the past three months
- Have access to an Internet-enabled computer or tablet at home, or ability to connect a BIDMC-provided tablet to the internet, with private space to complete cognitive testing
- Capable of and willing to provide written informed consent
Who cannot join
- Evidence of significant cognitive impairment or dementia
- Contraindications for TMS or MRI
- Current psychological treatment for insomnia
- Uncontrolled moderate-to-severe obstructive sleep apnea or other untreated sleep disorder (e.g., Restless Leg Syndrome, Periodic Limb Movement Disorder, parasomnia). Sleep apnea that is managed (e.g., regular use of a CPAP) and stable for ≥3 months is allowed.
- Diagnosis of Parkinson's disease, Huntington's disease, Lewy-Body disease, or other neurological condition known to impact sleep
- Current diagnosis of major psychiatric disorder (well-controlled depression or anxiety is permitted)
Show all 9Show fewer
- Current opiate/opioid use
- Alcohol or drug abuse within the past year
- Irregular sleep schedule (bedtime before 8pm/after 2am OR wake time before 4am/after 10am), unless participant states they are willing and able to change if prompted.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Alex Clinical Research Coordinator, 617-667-0386, adiamon2@bidmc.harvard.edu
Peter J Fried, PhD, 617-807-0612, pfried@bidmc.harvard.edu
About this study
Official title: Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI
The goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia.
- Conditions
- Mild Cognitive Impairment (MCI), Insomnia
- Being tested
- Transcranial Magnetic Stimulation (TMS) therapy, Cognitive behavioral therapy for insomnia (CBT-I)
- Keywords
- transcranial magnetic stimulation, neuromodulation, cognitive behavioral therapy, CBT-I, TMS, sleep
- Medical subject headings
- Cognitive Dysfunction, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS) therapyDevice
Also called Intermittent theta-burst stimulation (iTBS)
Each treatment consists of 600 TMS pulses (~3 minutes) applied to the L-DLPFC
Cognitive behavioral therapy for insomnia (CBT-I)Behavioural
Also called SHUTi OASIS
9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)
| Study group | Role | What they receive |
|---|---|---|
| One (1) TMS treatment per day plus CBT-I | Active comparator | One (1) daily treatment of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program Receives: Device: Transcranial Magnetic Stimulation (TMS) therapy; Behavioral: Cognitive behavioral therapy for insomnia (CBT-I) |
| Two (2) TMS treatments per day plus CBT-I | Active comparator | Two (2) daily treatments, spaced 1 hour apart, of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program Receives: Device: Transcranial Magnetic Stimulation (TMS) therapy; Behavioral: Cognitive behavioral therapy for insomnia (CBT-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
The Insomnia Severity Index (ISI) is a brief self-assessment tool used to measure the severity of insomnia. It consists of seven questions that evaluate sleep problems, their impact on daily life, and the individual's level of concern about their sleep issues. The total score helps to categorize the severity of insomnia from mild to severe.
Measured: Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)
Paired Associative Learning test (CANTAB)
The Paired Associative Learning (PAL) test is a computer-based cognitive assessment that evaluates memory and learning. In the test, participants are shown patterns and must remember the locations of these patterns on a screen. It is commonly used to assess spatial memory and detect early signs of memory-related conditions like Alzheimer's disease.
Measured: Baseline, Week 3, Week 12, 6 Months
Spatial Working Memory test (CANTAB)
The Spatial Working Memory (SWM) test is a computer-based task used to assess the ability to retain and manipulate spatial information. Participants must find hidden tokens within a series of boxes while avoiding revisiting previously searched locations. This test measures executive function and memory, and is often used in research on conditions affecting cognitive function.
Measured: Baseline, Week 3, Week 12, 6 months
Secondary outcomes (10)
Multidimensional Fatigue Symptoms Inventory
The Multidimensional Fatigue Symptom Inventory (MFSI) is a questionnaire designed to assess different aspects of fatigue. It measures five dimensions: general fatigue, emotional fatigue, physical fatigue, mental fatigue, and vigor (energy levels). The tool helps to provide a comprehensive understanding of an individual's fatigue symptoms and their impact on daily functioning.
Measured: Baseline, Week 3, Week 12, 6 months
Center for Epidemiologic Studies Depression scale
The Center for Epidemiologic Studies Depression scale (CES-D) is a self-report questionnaire designed to measure symptoms of depression in the general population. It consists of 20 questions that assess mood, behavior, and physical symptoms associated with depression over the past week. The CES-D is commonly used in research and clinical settings to screen for depressive symptoms and monitor changes in mood.
Measured: Baseline, Week 3, Week 12, 6 months
Match to Sample Visual Search test (CANTAB)
The Match to Sample Visual Search (MTS) test is a computerized assessment that measures visual recognition and attention. In the test, participants are shown a sample pattern and must quickly identify the matching pattern from a selection of similar images. It evaluates processing speed, visual memory, and attention to detail, and is often used to study cognitive functions in various neurological and psychiatric conditions.
Measured: Baseline, Week 3, Week 12, 6 months
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a quick test used by doctors and other healthcare professionals to check a person's thinking and memory skills. It takes about 10-15 minutes and looks at things like attention, memory, language, and problem-solving. It's often used to help spot early signs of conditions like dementia or mild cognitive impairment.
Measured: Baseline, Week 3, Week 12, 6 months
Sleep efficiency (sleep diaries)
Sleep Efficiency is a measure derived from sleep diaries that indicates the percentage of time spent asleep while in bed, relative to the total time spent in bed. It is calculated by dividing the total sleep time by the total time in bed and multiplying by 100 to get a percentage. A higher sleep efficiency typically suggests more consolidated sleep, while lower sleep efficiency can indicate difficulties with sleep onset or frequent awakenings.
Measured: Week 3, Week 13, 6 months
Sleep After Wake Onset (sleep diaries)
Sleep After Wake Onset (SAWO) is a measure derived from sleep diaries that captures the amount of time a person manages to sleep after experiencing an initial awakening during the night. It represents the total time spent asleep between waking up and the final morning awakening, providing insight into the continuity of sleep and the ability to return to sleep after disruptions.
Measured: Week 3, Week 13, Week 40
Sleep Onset Latency (sleep diaries)
Sleep Onset Latency (SOL) is a measure derived from sleep diaries that indicates the amount of time it takes to fall asleep after going to bed with the intention of sleeping. It is typically recorded in minutes and reflects how easily a person initiates sleep. Longer sleep onset latency may indicate difficulty falling asleep, while shorter latency suggests quicker sleep initiation.
Measured: Week 3, Week 13, Week 40
Sleep efficiency (actigraphy)
Sleep Efficiency is a measure derived from actigraphy that indicates the percentage of time spent asleep while in bed, relative to the total time spent in bed. It is calculated by dividing the total sleep time by the total time in bed and multiplying by 100 to get a percentage. A higher sleep efficiency typically suggests more consolidated sleep, while lower sleep efficiency can indicate difficulties with sleep onset or frequent awakenings.
Measured: Week 3, Week 13, 6 months
Sleep After Wake Onset (actigraphy)
Sleep After Wake Onset (SAWO) is a measure derived from actigraphy that captures the amount of time a person manages to sleep after experiencing an initial awakening during the night. It represents the total time spent asleep between waking up and the final morning awakening, providing insight into the continuity of sleep and the ability to return to sleep after disruptions.
Measured: Week 3, Week 13, Week 40
Sleep Onset Latency (actigraphy)
Sleep Onset Latency (SOL) is a measure derived from actigraphy that indicates the amount of time it takes to fall asleep after going to bed with the intention of sleeping. It is typically recorded in minutes and reflects how easily a person initiates sleep. Longer sleep onset latency may indicate difficulty falling asleep, while shorter latency suggests quicker sleep initiation.
Measured: Week 3, Week 13, Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 May 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- 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
- Model description
- This study will test the combination of neuromodulation by repetitive transcranial magnetic stimulation (rTMS) with cognitive behavioral therapy for insomnia (CBT-I). All participants will receive the active intervention. Participants will be randomized to receive one or two treatments of rTMS per day.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia
- Responsible party
- Principal investigator, Peter J. Fried, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687161
- Sponsor's protocol ID
- 2024P000708
- Other IDs
- A2024034S
- Status last verified
- Oct 2025
- First submitted
- 12 Nov 2024
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be made available for qualified researchers approximately.
Publications
Diamond AB, Fried PJ, Buss SS, Mullington JM, Brown JC, MacDonnell K, Mattos MK. Treating insomnia in mild cognitive impairment: a novel approach combining transcranial magnetic stimulation with cognitive behavioral therapy. Int Rev Psychiatry. 2026 May 19:1-17. doi: 10.1080/09540261.2026.2671089. Online ahead of print.
PubMed 42157607
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation and Cognitive Behavioral Therapy for Insomnia in MCI
- ClinicalTrials.gov ID
- NCT06687161
- Acronym / sponsor ID
- 2024P000708
- Conditions
- Mild Cognitive Impairment (MCI), Insomnia
- Keywords
- transcranial magnetic stimulation, neuromodulation, cognitive behavioral therapy, CBT-I, TMS, sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- University of Virginia
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 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.
The goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will test the combination of neuromodulation by repetitive transcranial magnetic stimulation (rTMS) with cognitive behavioral therapy for insomnia (CBT-I). All participants will receive the active intervention. Participants will be randomized to receive one or two treatments of rTMS per day.
| Arm | Type | Receives |
|---|---|---|
| One (1) TMS treatment per day plus CBT-I | Active comparator | Device: Transcranial Magnetic Stimulation (TMS) therapy, Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)One (1) daily treatment of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program |
| Two (2) TMS treatments per day plus CBT-I | Active comparator | Device: Transcranial Magnetic Stimulation (TMS) therapy, Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)Two (2) daily treatments, spaced 1 hour apart, of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 60 years or older
- Speak and read English
- Clinical diagnosis of MCI or Subjective Cognitive Impairment (SCI)-a perceived gradual worsening in cognitive ability relative to one's younger self, or peer group-reported by either the participant or informant
- Reported insomnia symptoms (sleep-onset and/or sleep maintenance) that cause significant distress or impairment in social, occupational, or other areas of functioning over the past three months
- Have access to an Internet-enabled computer or tablet at home, or ability to connect a BIDMC-provided tablet to the internet, with private space to complete cognitive testing
Key exclusion criteria (9 listed)
- Evidence of significant cognitive impairment or dementia
- Contraindications for TMS or MRI
- Current psychological treatment for insomnia
- Uncontrolled moderate-to-severe obstructive sleep apnea or other untreated sleep disorder (e.g., Restless Leg Syndrome, Periodic Limb Movement Disorder, parasomnia). Sleep apnea that is managed (e.g., regular use of a CPAP) and stable for ≥3 months is allowed.
- Diagnosis of Parkinson's disease, Huntington's disease, Lewy-Body disease, or other neurological condition known to impact sleep
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) therapyAlso: Intermittent theta-burst stimulation (iTBS)Each treatment consists of 600 TMS pulses (~3 minutes) applied to the L-DLPFC | Device | One (1) TMS treatment per day plus CBT-I, Two (2) TMS treatments per day plus CBT-I |
| Cognitive behavioral therapy for insomnia (CBT-I)Also: SHUTi OASIS9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness) | Behavioural | One (1) TMS treatment per day plus CBT-I, Two (2) TMS treatments per day plus CBT-I |
Primary outcome
Insomnia Severity Index
Time frame: Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)
The Insomnia Severity Index (ISI) is a brief self-assessment tool used to measure the severity of insomnia. It consists of seven questions that evaluate sleep problems, their impact on daily life, and the individual's level of concern about their sleep issues. The total score helps to categorize the severity of insomnia from mild to severe.
Paired Associative Learning test (CANTAB)
Time frame: Baseline, Week 3, Week 12, 6 Months
The Paired Associative Learning (PAL) test is a computer-based cognitive assessment that evaluates memory and learning. In the test, participants are shown patterns and must remember the locations of these patterns on a screen. It is commonly used to assess spatial memory and detect early signs of memory-related conditions like Alzheimer's disease.
Spatial Working Memory test (CANTAB)
Time frame: Baseline, Week 3, Week 12, 6 months
The Spatial Working Memory (SWM) test is a computer-based task used to assess the ability to retain and manipulate spatial information. Participants must find hidden tokens within a series of boxes while avoiding revisiting previously searched locations. This test measures executive function and memory, and is often used in research on conditions affecting cognitive function.
10 secondary outcomes
Multidimensional Fatigue Symptoms Inventory
Time frame: Baseline, Week 3, Week 12, 6 months
Center for Epidemiologic Studies Depression scale
Time frame: Baseline, Week 3, Week 12, 6 months
Match to Sample Visual Search test (CANTAB)
Time frame: Baseline, Week 3, Week 12, 6 months
Montreal Cognitive Assessment
Time frame: Baseline, Week 3, Week 12, 6 months
Sleep efficiency (sleep diaries)
Time frame: Week 3, Week 13, 6 months
Sleep After Wake Onset (sleep diaries)
Time frame: Week 3, Week 13, Week 40
Sleep Onset Latency (sleep diaries)
Time frame: Week 3, Week 13, Week 40
Sleep efficiency (actigraphy)
Time frame: Week 3, Week 13, 6 months
Sleep After Wake Onset (actigraphy)
Time frame: Week 3, Week 13, Week 40
Sleep Onset Latency (actigraphy)
Time frame: Week 3, Week 13, Week 40
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 24 Oct 2025.
- Derived from this study: PubMed 42157607Diamond AB, Fried PJ, Buss SS, Mullington JM, Brown JC, MacDonnell K, Mattos MK. Treating insomnia in mild cognitive impairment: a novel approach combining transcranial magnetic stimulation with cognitive behavioral therapy. Int Rev Psychiatry. 2026 May 19:1-17. doi: 10.1080/09540261.2026.2671089. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified data will be made available for qualified researchers approximately.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) therapy and Cognitive behavioral therapy for insomnia (CBT-I) in people with Mild Cognitive Impairment (MCI) and Insomnia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 24 Oct 2025. 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 United States. 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?
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 Alex Clinical Research Coordinator (617-667-0386, adiamon2@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)). The study lists 3 primary outcomes in all. 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 NCT06687161, which also lists 1 linked publication.
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 24 Oct 2025.