Recruiting

TMS & CBT

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06687161

Conditions

Mild Cognitive Impairment (MCI)

Insomnia

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation (TMS) therapy

Cognitive behavioral therapy for insomnia (CBT-I)

Study Details

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

Study ID

NCT06687161

Start date

May 1, 2025

Status verified date

Oct, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: One (1) TMS treatment per day plus 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

active comparator: Two (2) TMS treatments per day plus 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

Interventions

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)

Primary outcome measure

  • Insomnia Severity Index [ Time Frame: Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up) ]
  • Paired Associative Learning test (CANTAB) [ Time Frame: Baseline, Week 3, Week 12, 6 Months ]
  • Spatial Working Memory test (CANTAB) [ Time Frame: Baseline, Week 3, Week 12, 6 months ]

Central Contacts and Locations

Central contacts

Alex Clinical Research Coordinator

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

Peter J Fried, PhD

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

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Alex Clinical Research Coordinator

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

Peter J Fried, PhD

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

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2025-10-24.