Neuromodulation and fMRI in Neurodegenerative Diseases Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorSunnybrook Health Sciences Centre
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial Alternating Current Stimulation
DeviceApplication of low amplitude alternating electric current across the participant's scalp.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
2 yearsSecondary outcomes
1
Use of resting state fMRI functional connectivity to assess acute and lasting neurophysiological effects of tACS
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.
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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