Alzheimer Disease Clinical Trial
— Deep-HiPsOfficial title:
Noninvasive Temporal Interference Stimulation: An Approach for Modulating Associative Memory by Targeting Deep-brain Targets
Verified date | October 2023 |
Source | Masaryk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Alzheimer's disease and its preclinical stages are characterized by progressive neurodegenerative changes in the hippocampi and default mode network resulting in dysfunctions in episodic memory and its central part the associative memory. Associative memory allows for learning and remembering the relationship between unrelated items. Previous research suggests that non-invasive brain stimulation can influence associative memory but with the caveat of quite a small precision and relatively small effects due to the ability only influence superficial brain areas. Novel Brain stimulation techniques such as temporal interference stimulation (TIS) allow overcoming these caveats by allowing focal non-invasive deep brain stimulation. The main goal of this pilot clinical trial is to modulate associative memory among healthy seniors by influencing the cortico-hippocampal circuits using TIS. Secondly, the goal is to use functional magnetic resonance imaging (fMRI) and EEG to explore the neural correlates of TIS effects on brain networks and find biomarkers that allow predicting better response to brain stimulation.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 12, 2025 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Intact cognition - with the ability to comprehend the experimental task - right-handed Exclusion Criteria: - left-handed - severe internal disease, cancer - brain tumour, intracranial surgery, psychiatric disorder - severe neurological brain disease; i.e.: epilepsy, stroke etc. - the presence of a pacemaker/defibrillator, metal incompatible with magnetic resonance in the body - incapacitating musculoskeletal disorders - cognitive impairment based on screening tests - severe impairment of vision |
Country | Name | City | State |
---|---|---|---|
Czechia | CEITEC Masaryk university | Brno |
Lead Sponsor | Collaborator |
---|---|
Masaryk University | St. Anne's University Hospital Brno, Czech Republic |
Czechia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy in Face-Name association task | The face-name association task will be composed of blocks of encoding and recall. Each block contained a unique face-name pair. Multiple pairs followed by a delay and a recall period, where participants tried to select the correct name of each face out of five options (i.e., one target name, two foil names that were present in the block but associated with a different face, and two distracting names that were not present during the task). After each name selection, participants were asked to rate their choice confidence (1, not confident at all to 4, extremely confident) | Measured during stimulation procedure; assessed through study completion, an average of 2 years | |
Primary | Speed in Face-Name association task | The face-name association task will be composed of blocks of encoding and recall. Each block contained a unique face-name pair. Multiple pairs followed by a delay and a recall period, where participants tried to select the correct name of each face out of five options (i.e., one target name, two foil names that were present in the block but associated with a different face, and two distracting names that were not present during the task). After each name selection, participants were asked to rate their choice confidence (1, not confident at all to 4, extremely confident) | Measured during stimulation procedure; assessed through study completion, an average of 2 years | |
Secondary | changes in resting-state functional connectivity in regions of interest | resting-state fMRI: the analysis will be primarily focused on alterations within nodes in the Default mode Network and between network connectivity; Secondary focus on task-positive networks, namely: Central executive network and Dorsal attentional network | Baseline measurement approximately 20 minutes prior stimulation; immediately after stimulation protocol up to 30 minutes | |
Secondary | Transcranial magnetic stimulation evoked activity change over the regions of interest (Precuneus, prefrontal cortex) | Transcranial magnetic stimulation (TMS) evoked potentials; Investigation of local cortical circuits and networks activated following stimulation | Baseline measurement approximately 30 minutes prior stimulation; immediately after stimulation protocol up to 40 minutes |
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