Neuromodulation and fMRI in Neurodegenerative Diseases Study
A Pilot Study in Defining the Potential of Transcranial Alternating Current Neuromodulation for Stabilizing Memory and Improving Functional Connectivity in Neurodegeneration
Study Overview
Status
Intervention / Treatment
Detailed Description
The participants will first be scanned on a 3T MRI system (at Sunnybrook Health Sciences Centre) using a multi-channel receive head coil.
The MRI protocol will comprise a T1-weighted structural scan to provide anatomical information and guide prescription of the geometry of subsequent functional scans and subsequent tACS montage (stimulation electrode geometry). Next, a Chemical Exchange Saturation Transfer (CEST) sequence will be run. CEST is a non-invasive alternative to positron emission tomography (PET) imaging that will allow us to make measurements of cerebral metabolism. Glucosamine will be used as an orally administered contrast agent. The next sequence of the MRI protocol will be the resting state blood-oxygenation level dependent (BOLD) fMRI, examining brain function while the patient is idle (i.e., not performing a specific task). Finally, a pseudo-continuous arterial spin labeling (pCASL)/BOLD fMRI sequence will be acquired during which participant may intermittently hear a variety of sounds and be asked to perform a simple memory task, inducing stimulus/task processing related neuronal activations in the brain. The pCASL sequence uses radiofrequency (RF) fields to magnetically "tag" blood in the carotid arteries, thus allowing estimation of cerebral blood flow.
EEG recordings will be performed after the MRI scan. Participants will have electrodes affixed to their scalp with a water soluble paste. After electrode application, participants will be escorted to a sound-attenuating chamber for testing. The participant will be seated in a comfortable reclining chair. Instructions will be given to the subject and testing started shortly after. Testing procedures will include monitoring brain responses to sounds or during performance of the aforementioned simple memory task. Sounds will be presented at a comfortable listening level though headphones or speakers.
After the initial baseline MRI and EEG have been acquired, participants will receive 20 minutes of tACS. The tACS will be delivered via a high definition-tACS system (Soterix Medical, New York, NY). The system is currently approved by US Federal Law as an investigational device. The system includes a cap with 32 electrodes that can be used to deliver stimulation. The electrodes will be chosen through finite head modelling to best stimulate the occipitoparietal cortex. The intensity of stimulation delivered through each electrode will not exceed 3 mA, as prescribed by the hardware-based safety limits.
The participants will undergo post-tACS imaging, on the first and final days of treatment administration and at a 1-month follow up visit, using the same sequences as in the baseline scans described above.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bojana Stefanovic, PhD
- Phone Number: 1-416-480-5726
- Email: bojana@sri.utoronto.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
All participants will receive transcranial alternating current stimulation.
|
Application of low amplitude alternating electric current across the participant's scalp.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of cognitive benefits post tACS intervention
Time Frame: 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of resting state fMRI functional connectivity to assess acute and lasting neurophysiological effects of tACS
Time Frame: 2 years
|
The secondary objective is to assess if the anticipated tACS mediated cognitive improvements are correlated with a neuroimaging metric such as changes in resting state fMRI connectivity.
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Wounds and Injuries
- Pathologic Processes
- Neurocognitive Disorders
- Cognition Disorders
- Craniocerebral Trauma
- Trauma, Nervous System
- Brain Injuries
- Pathological Conditions, Signs and Symptoms
- Brain Injuries, Traumatic
- Cognitive Dysfunction
- Nerve Degeneration
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- 5787
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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