Treating Insomnia in Mild Cognitive Impairment with TMS and CBT-I

This study is looking for people aged 60 or older who have mild cognitive impairment (MCI) or subjective cognitive impairment (SCI) and also experience insomnia. The goal is to see if combining two treatments can improve sleep quality. These treatments are Transcranial Magnetic Stimulation (TMS) therapy, which uses magnetic pulses to stimulate the brain, and Cognitive Behavioral Therapy for Insomnia (CBT-I), a program delivered online to help you change sleep habits. Researchers will measure your insomnia symptoms and memory skills at different times to see how well the treatments work. This study plans to include 30 participants, but its current status is unclear.

Study design: This interventional study plans to enroll 30 participants. It combines two treatments: Transcranial Magnetic Stimulation (TMS) therapy and Cognitive Behavioral Therapy for Insomnia (CBT-I).
What's involved: You would receive TMS therapy for three weeks, followed by a nine-week online CBT-I program. You would have assessments at the start, after TMS, after CBT-I, and then a final check-up six months later.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for six months after completing the CBT-I program.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Treating Insomnia in Mild Cognitive Impairment

Recruiting

NAAges 60+InterventionalTreatment

Beth Israel Deaconess Medical Center

~30 participants

Updated 2025-10-24 on ClinicalTrials.gov

What's tested:Transcranial Magnetic Stimulation (TMS) therapyCognitive behavioral therapy for insomnia (CBT-I)

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Insomnia Severity Index

Measured over Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)

+2 more outcomes measured

Conditions

Mild Cognitive Impairment (MCI)

Insomnia

Where it's being run

1 sites across 1 states

Massachusetts1

Who to contact

Alex Clinical Research Coordinator

[email protected]

617-667-0386

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

Insomnia Severity IndexBaseline, 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)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)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.

Trialytics