Health TrialsbyHealthPanel

Language Network Prehab Via fMRI Neurofeedback

ConditionsGliomaGlioma Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

This is an interventional neuroimaging study that will examine whether fMRI neurofeedback can shift language network activity away from regions affected by glioma prior to surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Diagnosis of WHO grade II-III glioma involving eloquent language cortex

Scheduled for surgical resection

Disqualifiers

Severe baseline aphasia precluding task performance

Contraindications to MRI

Significant cognitive/psychiatric comorbidity limiting compliance

Concurrent enrollment in other interventional trials

Trial design

Design model

Single group

Treatments tested in this trial

  • fMRI

    Device

    Real-time functional magnetic resonance imaging (fMRI) neurofeedback (NF)

Treatment groups

4 Participants
are divided into 1 treatment group
Group A: fMRI neurofeedback (NF) and GliomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants enrolled to assess feasibility

Number of participants enrolled out of all screened

Time frame
up to 6 months
2

Number of participants completing all study visits to assess feasibility

Number of participants completing all study visits within the standard presurgical window

Time frame
From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days
3

Number of device-related adverse events to assess safety

Number of device-related adverse events

Time frame
From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days
4

Mean score Patient Experience Questionnaire (PEQ) to assess acceptability

Participant-reported acceptability and perceived burden as measured by the Patient Experience Questionnaire (PEQ). Total score range 1-5 with higher scores indicating better experiences.

Time frame
Post surgery at 10 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Source ClinicalTrials.gov
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