Cerebellar Modulation of Cognition in Psychosis

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Mclean Hospital
Study ID
NCT06107764
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • intermittant theta burst stimulation (iTBS) — DEVICE
    iTBS consists of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses.
  • continuous theta burst stimulation (cTBS) — DEVICE
    cTBS consists of 3 pulses at 50 Hz repeated at 5 Hz (every 200ms) continuously for a total of 600 pulses
  • sham rTMS — DEVICE
    sham rTMS does not deliver a significant change in magnetic field strength

Study Details

The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks). Participants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.

Key Dates

Start date
Jul 31, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
95 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: Intermittent theta burst stimulation (iTBS)
    Participants complete MRI scanning and cognitive testing followed by rTMS (iTBS pattern) followed by repeat cognitive testing and MRI scanning
  • Active Comparator: continuous theta burst stimulation (cTBS)
    Participants complete MRI scanning and cognitive testing followed by rTMS (cTBS pattern) followed by repeat cognitive testing and MRI scanning
  • Sham Comparator: sham rTMS
    Participants complete MRI scanning and cognitive testing followed by sham rTMS followed by repeat cognitive testing and MRI scanning

Primary Outcome Measure

BACS Symbol Coding test [ Time Frame: eight minutes before TMS and one minute after TMS on each of the three TMS visit days ]

Locations (2)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Madelaine Nye, B.S.
[email protected]
617-855-2370
Kathryn E Lewandowski, Ph.D. (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Madelaine Nye
[email protected]
617-632-7956
Roscoe O Brady, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Belmont, MA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
McLean Hospital· Belmont, MABeth Israel Deaconess Medical Center· Boston, MA

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