Transcranial Magnetic Stimulation (TMS) therapyCognitive behavioral therapy for insomnia (CBT-I)
Transcranial Magnetic Stimulation (TMS) therapy: Each treatment consists of 600 TMS pulses (\~3 minutes) applied to the L-DLPFC
Cognitive behavioral therapy for insomnia (CBT-I): 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 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.
Eligibility
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
Insomnia Severity Index — 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) — 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.
Trial sites (1)
Facility
City
Region
Status
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Recruiting
More Beth Israel Deaconess Medical Center trials in Israel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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