Neuromodulation and fMRI in Neurodegenerative Diseases Study

NCT06873750 | Not Yet Recruiting FDA Device

• 1 other identifier: 5787
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

In addition to neuronal loss, dysfunction in brain network connectivity has been identified as a correlate of cognitive deficits in neurodegenerative and post-traumatic brain injury states. Transcranial alternating current stimulation (tACS) has been suggested as a promising, non-invasive, method of normalizing network connectivity and hence improving cognition, notably memory. This study will examine the efficacy of tACS at improving working memory performance in patients with neurodegeneration and its correlation to changes in network connectivity, based on functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) imaging data.

Conditions

Mild Cognitive Impairment; Traumatic Brain Injury; Neurodegeneration

Keywords

Transcranial Alternating Current Stimulation; Neuromodulation; Functional Magnetic Resonance Imaging; Cognitive Assessment

Outcome Measures

Primary Outcomes (1)

• Assessment of cognitive benefits post tACS intervention

  The first projected outcome is to demonstrate the feasibility of using tACS as a treatment for working memory deficits in patients in neurodegenerative disorders or post-traumatic brain injury cognitive impairment. The success of which will be assessed using the results of neurophysiological testing such as Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) scores (with a lower score compared to pre-tACS baseline indicating improved cognition; scale ranges from 0-70 with 0 indicating no cognitive impairment and scores \>18 indicating some degree of impairment) and examining if the scores improve before and after administration of tACS.

  2 years

Secondary Outcomes (1)

• Use of resting state fMRI functional connectivity to assess acute and lasting neurophysiological effects of tACS

  2 years

Study Arms (1)

Treatment

EXPERIMENTAL

All participants will receive transcranial alternating current stimulation.

Device: Transcranial Alternating Current Stimulation

Interventions

Transcranial Alternating Current Stimulation DEVICE

Application of low amplitude alternating electric current across the participant's scalp.

Also known as: Soterix Medical MxN-33 high definition transcranial electrical stimulator

Treatment

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 25 years of age;
• Have no contraindications to MRI
• Have received 8 or more years of formal education
• Be fluent in English
• Cohort a. must be followed at Sunnybrook Health Sciences Center
• Cohort a:
• Have been diagnosed with a suspected neurodegenerative disorder or traumatic brain injury (TBI) with memory deficits impacting functional status
• In case of TBI, cognitive impairment has persisted at least three months post-injury
• Received score of 16 or lower on the Mini Mental State Examination (MMSE)
• Cohort b:
• Have no prior diagnosis of a neurodegenerative disorder or post-traumatic brain injury cognitive deficits
• Be experiencing healthy aging and be age and sex matched to Cohort a.

You may not qualify if:

• Have any contraindications to MRI
• Be pregnancy
• Have any major comorbid medical conditions (as determined by investigators - e.g., comorbid neurological diseases, uncontrolled hypertension or diabetes, malignancy) or major comorbid psychiatric conditions (as determined by investigators - e.g., schizophrenia or bipolar disorder)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

MeSH Terms

Conditions

Cognitive Dysfunction; Brain Injuries, Traumatic; Nerve Degeneration

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Bojana Stefanovic, PhD

CONTACT

1-416-480-5726; bojana@sri.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Senior Scientist, Physical Sciences, Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute

Model Details: This study will follow a single group assignment model. All participants will receive the tACS treatment. The primary goal is proof-of concept that tACS is a feasible, non-invasive treatment that provides some amelioration in working memory, correlated with observable changes in EEG and fMRI imaging metrics.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: March 13, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share