Treating Insomnia in Mild Cognitive Impairment

NCT06687161 | Recruiting FDA Device

• 2 other identifiers: 2024P000708A2024034S
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment (MCI); Insomnia

Keywords

transcranial magnetic stimulation; neuromodulation; cognitive behavioral therapy; CBT-I; TMS; sleep

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (10)

• Multidimensional Fatigue Symptoms Inventory

  Baseline, Week 3, Week 12, 6 months

• Center for Epidemiologic Studies Depression scale

  Baseline, Week 3, Week 12, 6 months

• Match to Sample Visual Search test (CANTAB)

  Baseline, Week 3, Week 12, 6 months

• Montreal Cognitive Assessment

  Baseline, Week 3, Week 12, 6 months

• Sleep efficiency (sleep diaries)

  Week 3, Week 13, 6 months

Other Outcomes (1)

• Cortical Plasticity

  Baseline (first day of TMS therapy)

Study Arms (2)

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

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

Device: Transcranial Magnetic Stimulation (TMS) therapy; Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)

Interventions

Transcranial Magnetic Stimulation (TMS) therapy DEVICE

Each treatment consists of 600 TMS pulses (\~3 minutes) applied to the L-DLPFC

Also known as: Intermittent theta-burst stimulation (iTBS)

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) 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)

Also known as: SHUTi OASIS

One (1) TMS treatment per day plus CBT-I; Two (2) TMS treatments per day plus CBT-I

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• University of Virginia: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders

Interventions

Transcranial Magnetic Stimulation; Therapeutics; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Alex Clinical Research Coordinator

CONTACT

617-667-0386; adiamon2@bidmc.harvard.edu

Peter J Fried, PhD

CONTACT

617-807-0612; pfried@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Approximately 1 year following the conclusion of the study for at least 5 years
• Access Criteria: 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.

Locations

US (1)