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| ID | Type | Description | Link |
|---|---|---|---|
| A2024034S | Other Grant/Funding Number | BrightFocus Foundation |
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| Name | Class |
|---|---|
| University of Virginia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) therapy | Device | Each treatment consists of 600 TMS pulses (~3 minutes) applied to the L-DLPFC |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, Week 3, Week 12, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cortical Plasticity | Cortical plasticity is a measure of the efficacy of long-term potentiation (LTP)-neuroplasticity. It will be measured as the change in the TMS-evoked EEG potential (TEP) following iTBS. | Baseline (first day of TMS therapy) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Clinical Research Coordinator | Contact | 617-667-0386 | adiamon2@bidmc.harvard.edu | |
| Peter J Fried, PhD | Contact | 617-807-0612 | pfried@bidmc.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42157607 | Derived | 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. |
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De-identified data will be made available for qualified researchers approximately.
Approximately 1 year following the conclusion of the study for at least 5 years
Researchers at universities and academic medical centers can request de-identified data by sending an email to the PI and describing the nature of the request.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D013812 | Therapeutics |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
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| Cognitive behavioral therapy for insomnia (CBT-I) | Behavioral | 9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness) |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 3, Week 13, Week 40 |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |