Neurofeedback in Clinical High Risk

NCT06492343 | Not Yet Recruiting

• 1 other identifier: 206731
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this trial is to test whether fMRI based neurofeedback from default mode network (DMN) will reduce DMN hyperconnectivity in clinical high risk individuals, which will lead to reductions in clinical symptoms and improve cognitive performance.

Conditions

Real Neurofeedback From DMN; Sham Neurofeedback From Motor Cortex

Keywords

fMRI, neurofeedback, DMN, functional connectivity

Outcome Measures

Primary Outcomes (2)

• rs-FMRI DMN changes, post-NFB

  reductions in resting state functional connectivity MPFC-PPC in real NFB group only

  three weeks

• rs fMRI MPFC-STG changes, post-NFB

  reductions in MPFC-PCC resting state functional connectivity, post NFB, in real NFB group only

  three weeks

Secondary Outcomes (1)

• GABA in MPFC

  one week

Study Arms (2)

real NFB from DMN

EXPERIMENTAL

Participants will receive NFB from their DMN

Other: fMRI based neurofeedback

sham NFB from motor cortex

EXPERIMENTAL

Participants will receive NFB from their motor cortex

Other: fMRI based neurofeedback

Interventions

fMRI based neurofeedback OTHER

participants will receive neurofeedback from their brain in order to modify their own brain function

real NFB from DMN; sham NFB from motor cortex

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Native speaker or early learner (by age of 6) of English
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• years old
• Native speaker or early learner (by age of 6) of English
• Provides a match with CHR subject on demographic matching variables

You may not qualify if:

• For CHR:
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• Meeting DSM-5 criteria for lifetime psychotic disorder, including affective psychoses
• WASI-II IQ \< 70
• Psychosis risk symptoms caused by other psychiatric disorders (including substance use/misuse)
• Congenital or acquired CNS disorder that could account for psychosis-risk or cognitive symptoms
• Medication that interferes with assessment / presentation of psychosis risk or that could account for psychosis risk symptoms
• Antipsychotic medication administered in the absence of evidence the individual was still in the CHR state when treatment began
• Inability or refusal to provide informed consent
• For HC:
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• Meets criteria for a psychosis-risk syndrome
• Current or previous diagnosis for psychotic di sorder
• DSM-5 Cluster A personality disorder
• First degree biological relative with psychotic disorder or psychotic symptoms

Sponsors & Collaborators

• Boston VA Research Institute, Inc.: lead

Study Officials

• margaret niznikiewicz, phd

  Boston VA Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

margaret niznikiewicz, phd

CONTACT

6176534627; margaret_niznikiewicz@hms.harvard.edu

Susan Whitfield-Gabrieli, PhD

CONTACT

s.whitfield-gabrieli@northeastern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one group receiving NFB from DMN another group receiving NFB from motor cortex

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 9, 2024

Record last verified: 2024-06