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The purpose of this study is to obtain preliminary data in advance of a larger clinical trial designed to test whether repeated, daily sessions of at-home transcranial alternating current stimulation (tACS) can lead to a clinically significant improvement in patients with AD.
Given the potentially fragile patient population, the investigators propose a pilot study to test feasibility and safety (primary). In this pilot study 30 mild-to-moderate AD patients will be enrolled. The intervention will consist of daily model-optimized and individualized tES delivered for 8 weeks, 5 days per week (40 sessions). tACS will be applied daily for 1 hour and will be paired with extensive neuroimaging, neurophysiological and neuropsychological evaluation at several time points (pre and post treatment) to better characterize patients and their response to treatment. The physiological target of treatment will be to increase gamma activity in the pre-frontal cortex, as this has been associated with cognitive decline in AD, and prior tES work targeting PFC gamma oscillations has shown promising results.
The investigators hypothesize that active tACS treatment will result in a comparatively slower progression of cognitive decline and loss of gamma power as compared to sham treatment. To assess this, in this pilot study, a cross-over design will be used. Treatment will be multisession since prior tES work indicates a cumulative effect of each session with stronger therapeutic effects, in line with the underlying Hebbian mechanisms putatively involved in non-invasive brain stimulation.
The NEUROTWIN project is grounded in the hypothesis that brain oscillations, particularly in the gamma band (40 Hz), play a central role in cognitive processes, and their disruption is associated with the cognitive decline seen in Alzheimer's disease (AD). Gamma oscillations are generated by excitatory-inhibitory neural circuits that include GABAergic interneurons, which are often impaired in patients with AD. This deficit is linked to reduced synchronization of gamma oscillations, which are essential for cognitive functions such as memory and attention.
Recent studies have shown that inducing gamma oscillations can reduce levels of amyloid-beta (Aβ) and phosphorylated tau (p-tau)-key pathological markers of AD-in animal models of the disease. These findings suggest that stimulating gamma oscillations through non-invasive methods may have a positive impact on specific brain functions affected by AD. Transcranial electrical stimulation (tES), including transcranial alternating current stimulation (tACS), can modulate these gamma oscillations in a safe, non-invasive manner.
The rationale for targeting gamma oscillations with tACS in Alzheimer's therapy is supported by:
However, a significant constraint of many Non-invasive brain stimulation protocols is their reliance on multiple sessions to achieve enduring effects. These sessions are typically conducted in clinical settings, necessitating patient travel. This obstacle hampers the delivery of extended interventions, particularly for individuals with neurodegenerative conditions. We thus adopt a home-based approach using tACS because of its ability to entrain gamma oscillations, commonly impaired in AD, and its low cost and potential for home-based application. in particular, the Starstim-home device has been developed for home use with remote supervision, making gamma stimulation accessible and scalable for patients. A home-based protocol allows for a higher treatment frequency (5 times a week for 8 weeks per arm), reducing costs and increasing convenience for patients and caregivers.
In this study, participants will use the Starstim-home device for one-hour tACS sessions (real or sham), targeting the fronto-temporal cortex. These electrode positions were obtained from a group montage optimization using the Stimweaver algorithm performed on a database of biophysical head models of patients with AD, i.e. volume conductor models built from structural head T1w-MRIs that model the passive electrical properties of the primary head tissues.
The device will be configured to administer personalized and model-optimized gamma-frequency tES, always assuming a 180° phase-shift between the currents in the electrodes in the opposite hemispheres. This is done using a linear model that predicts the currents based on morphometric characteristics of the patient's scalp, namely the head perimeter along axial, sagittal, and coronal planes. The current intensity will be ramped up over the first 30 seconds, then sustained at the stimulation intensity for 60 minutes, then ramped down over the final 30 seconds for the Real condition. The Sham condition will rely on the classical 30-second ramp-up/ramp-down protocol.
The subject will receive a pre-configured Starstim Home Kit, including the device, tablet, all needed supplies, and training materials. The Starstim Home Kit tablet contains a sequence of simplified instructions and step-by-step touchscreen prompts for the participant/administrator to follow. This process has been designed to be easy to use, even for individuals who are not computer savvy.
The first two daily visits will be performed at the memory clinic. During the first daily visit, the study staff will lead a training session while the home-based administrator observes. The study staff will review the step-by-step process, the accompanying training manual, and the photos depicting each step. During the second daily visit, the administrator will then practice setting up the tES session on the participant with oversight and coaching from the study staff. The administrator will also be trained to take care of the devices. Then, caregivers or designated administrators will oversee the sessions at home, ensuring device use and protocol adherence under remote supervision by clinical staff.
In this randomized, double-blind, sham-controlled, crossover pilot study, the participants will receive both active and sham tES conditions, each lasting 8 weeks, with a washout period of two months in between. tES sessions will be held daily, 5 days a week, for a total of 40 sessions per condition. Neuroimaging, neurophysiological, and cognitive assessments will occur at multiple points before, after, and in a follow-up period of two months for each treatment condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHAM-tACS | Sham Comparator | The Sham condition will rely on the classical ramp up/ramp down protocol, which is characterized by 30 seconds of tACS stimulation at the beginning and end of the protocol to help with blinding. During the rest of the stimulation period (1h) no stimulation will be derivered. |
|
| REAL-tACS | Experimental | The intervention will consist of daily model-optimized and individualized 40Hz-tACS delivered on the dorsolateral prefrontal and temporal cortex bilaterally. 40Hz-tACS will be applied daily for 1 hour, with a ramp up/down of 30 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial alternating current stimulation | Device | The intervention employs transcranial alternating current stimulation (tACS), a non-invasive brain stimulation technique designed to modulate neural oscillations in targeted brain regions. tACS operates by applying low-intensity, alternating electrical currents through electrodes placed on the scalp, synchronizing with the brain's natural frequency patterns. In this arm, a frequency of 40 Hz (gamma frequency) is used to enhance oscillatory activity related to cognitive functions often impaired in Alzheimer's disease (AD). The Neuroelectrics Starstim-home device will be used. This compact, portable device allows for easy use within the home setting, reducing the need for daily clinic visits. Designated caregivers will administer the one-hour tACS sessions under remote supervision via a digital monitoring portal, which tracks adherence, technical performance, and safety data in real time. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events and missed stimulation session | The investigators will collect data about electrode impedance, tACS progression, and session interruptions or terminations, whether voluntary or due to technical issues. These metrics, including the number of missed sessions, will aid in the assessment of feasibility. At the same time, any adverse events will be documented and used as the primary safety endpoint. | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) 14 immediately after the intervention and at a two-month follow-up | The Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) 14 is a standardized neuropsychological assessment used to measure the severity of symptoms of Alzheimer's Disease in different domains. The tasks assess the domains of language, praxis, memory, attention, visuospatial and executive function. The tasks include: word recall task, naming objects and fingers, commands, constructional praxis, ideational praxis, orientation, word recognition task, comprehension of spoken language, word finding difficulty, remembering test instructions, executive function, and number cancellation. The score range is from 0 to 70 with a lower score indicating more severe functional impairment. | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of change from baseline in the Clinical Dementia Rating scale (C.D.R.) sum of boxes immediately after the intervention and at a two-month follow-up | The Clinical Dementia Rating scale (C.D.R.) sum of boxes is used to characterize six domains of cognitive and functional performance applicable to Alzheimer's disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. The score range is from 0 to 18 with the higher score meaning greater disease severity. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of change from baseline in the Resting-state EEG activity in specific frequency band of relevance for AD immediately after the intervention and at a two-month follow-up | Resting state EEG and artifact recordings will be obtained by using 64 channels TMS-compatible EEG equipment (BrainAmp 32MRplus, BrainProducts GmbH, Munich, Germany) with the eyes open for five minutes. | From date of randomization until the date of last documented progression, assessed up to 8 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonia Bonni, PhD | I.R.C.C.S. Fondazione Santa Lucia | Study Chair |
| Martina Assogna, MD | I.R.C.C.S. Fondazione Santa Lucia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irccs Santa Lucia Foundation | Rome | ROME | 00179 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34958021 | Background | Dhaynaut M, Sprugnoli G, Cappon D, Macone J, Sanchez JS, Normandin MD, Guehl NJ, Koch G, Paciorek R, Connor A, Press D, Johnson K, Pascual-Leone A, El Fakhri G, Santarnecchi E. Impact of 40 Hz Transcranial Alternating Current Stimulation on Cerebral Tau Burden in Patients with Alzheimer's Disease: A Case Series. J Alzheimers Dis. 2022;85(4):1667-1676. doi: 10.3233/JAD-215072. | |
| 17562028 |
| Label | URL |
|---|---|
| Related Info | View source |
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This study is part of the 'Horizon 2020' project and all data will be made publicly available in a digital database at the conclusion of the study.
30/06/2025
The IPD supporting information will be made available upon request and accessed using a password.
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| sham transcranial alternating current stimulation | Device | The intervention employs transcranial alternating current stimulation (tACS), a non-invasive brain stimulation technique designed to modulate neural oscillations in targeted brain regions. tACS operates by applying low-intensity, alternating electrical currents through electrodes placed on the scalp, synchronizing with the brain's natural frequency patterns. In this arm, the stimulation will be delivered in 'sham' mode which is characterized by 30 seconds of tACS stimulation at the beginning and end of the protocol to help with blinding. During the rest of the stimulation period (1h) no stimulation will be delivered. The Neuroelectrics Starstim-home device will be used. This compact, portable device allows for easy use within the home setting, reducing the need for daily clinic visits. Designated caregivers will administer the sham tACS sessions under remote supervision via a digital monitoring portal, which tracks adherence, technical performance, and safety data in real time. |
|
| From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the AD Cooperative Study - Activities of Daily Living (ADCS-ADL) immediately after the intervention and at a two-month follow-up | The AD Cooperative Study - Activities of Daily Living (ADCS-ADL) includes 23 items that were derived from a larger set of items describing the performance of activities of daily living. The score range is from 0 to 78 with a lower score indicating more severe functional impairment. | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the Mini-Mental State Examination (MMSE) immediately after the intervention and at a two-month follow-up | The Mini-Mental State Examination (MMSE) is a brief, widely used valid, and reliable assessment of cognitive impairment. This 30-point questionnaire is used to screen and estimate the severity of cognitive impairment in addition to being used to follow the course of cognitive change over time. The test assesses orientation, attention and calculation, recall, language, repetition, and ability to follow complex commands. The score range is from 0 to 30, with lower score meaning greater cognitive impairment. | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the Frontal Assessment Battery (F.A.B.) immediately after the intervention and at a two-month follow-up | The Frontal Assessment Battery (F.A.B.) is a brief battery of six neuropsychological tasks designed to assess frontal lobe function at the bedside. The six FAB tasks explore cognitive and behavioral domains that are thought to be under the control of the frontal lobes, most notably conceptualization, and abstract reasoning, lexical verbal fluency and mental flexibility, motor programming and executive control of action, self-regulation, and resistance to interference, inhibitory control, and environmental autonomy. The range score is from 0 to 18 with the higher score meaning less frontal cognitive impairment. | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the Neuropsychiatric Inventory (NPI) immediately after the intervention and at a two-month follow-up | The Neuropsychiatric Inventory assesses behavioral disturbances in dementia. The NPI is a reliable and valid test measuring the following behavioral areas: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, night time behaviors, and eating disorders. The score range is from 0 to 144 with the higher score meaning more severe behavioural disturbances. | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) immediately after the intervention and at a two-month follow-up | The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form is a 16-item, self-report questionnaire that evaluates quality of life and satisfaction in several domains. The first 14 items assess satisfaction with (1) physical health, (2) mood, (3) work, (4) household activities, (5) social relationships, (6) family relationships, (7) leisure activities, (8) daily functioning, (9) sexual life, (10) economic status, (11) living/housing situation, (12) ability to get around physically, (13) vision, and (14) overall well-being. The last two items measure medications, and overall satisfaction and contentment. The items are scored on a 5-point Likert scale from 1 (not at all or never) to 5 (frequently or all the time), with higher scores indicating better enjoyment and satisfaction with life. The total score of the questionnaire is the sum of these 14 items ranging from 14 to 70. Higher scores mean better enjoyment and satisfaction with life. | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the Apathy Motivation Index immediately after the intervention and at a two-month follow-up | The apathy motivation index is a 18-item self-report questionnaire that assesses apathy in terms of Behavioral Activation (tendency to self-initiate goal-directed behavior), Social Motivation (level of engagement in social interactions) and Emotional Sensitivity (affective responses) using a 5-point Likert scale. Item scores are averaged to yield scores for subscales and a total score with higher scores indicating greater apathy (range 0-4). | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the short afferent inhibition (SAI) immediately after the intervention and at a two-month follow-up | This measure reflects the central cholinergic activity controlled by inhibitory circuits. | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the Repetitive TMS indexing long term potentiation (LTP) immediately after the intervention and at a two-month follow-up | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the transcranial evoked potentials (TEPs) and oscillatory activity over the fronto-temporal cortices immediately after the intervention and at a two-month follow-up | TMS-EEG protocol will be used to investigate changes in cortical reactivity, connectivity, and oscillatory evoked activity. A 64-channel TMS-compatible EEG equipment (BrainAmp 32MRplus, BrainProducts GmbH, Munich, Germany) will be used to collect data. A masking noise system will be used to reduce auditory evoked potential artifacts. The stimulation will take place over brain regions in the prefrontal and parietal lobes. | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the functional and structural connectivity immediately after the intervention and at a two-month follow-up | The MRI imaging will be conducted on a 3T Siemens Magnetom Prisma scanner with a 64-channel head-neck coil at the Neuroimaging department of IRCCS Santa Lucia Foundation (Rome, Italy). The subjects will be instructed to maintain their eyes open fixing a cross, not to focus their thoughts on any particular topic, and not to cross their arms or legs. The following sequences will be collected: Anatomical MRI, Diffusion MRI, Resting-state BOLD fMRI, and Resting-state ASL. | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Measurement of change from baseline in the Blood biomarkers immediately after the intervention and at a two-month follow-up | Blood biomarkers will be collected to detect plasmatic changes in amyloid beta, phosphorylated tau, and total tau, neurofilament light chain (NFL) (PG/ml). | From date of randomization until the date of last documented progression, assessed up to 8 months |
| Background |
| Thickbroom GW. Transcranial magnetic stimulation and synaptic plasticity: experimental framework and human models. Exp Brain Res. 2007 Jul;180(4):583-93. doi: 10.1007/s00221-007-0991-3. Epub 2007 Jun 12. |
| 20938352 | Background | Tadini L, El-Nazer R, Brunoni AR, Williams J, Carvas M, Boggio P, Priori A, Pascual-Leone A, Fregni F. Cognitive, mood, and electroencephalographic effects of noninvasive cortical stimulation with weak electrical currents. J ECT. 2011 Jun;27(2):134-40. doi: 10.1097/YCT.0b013e3181e631a8. |
| 34930421 | Background | Sprugnoli G, Munsch F, Cappon D, Paciorek R, Macone J, Connor A, El Fakhri G, Salvador R, Ruffini G, Donohoe K, Shafi MM, Press D, Alsop DC, Pascual Leone A, Santarnecchi E. Impact of multisession 40Hz tACS on hippocampal perfusion in patients with Alzheimer's disease. Alzheimers Res Ther. 2021 Dec 20;13(1):203. doi: 10.1186/s13195-021-00922-4. |
| 24345389 | Background | Ruffini G, Fox MD, Ripolles O, Miranda PC, Pascual-Leone A. Optimization of multifocal transcranial current stimulation for weighted cortical pattern targeting from realistic modeling of electric fields. Neuroimage. 2014 Apr 1;89:216-25. doi: 10.1016/j.neuroimage.2013.12.002. Epub 2013 Dec 15. |
| 17452283 | Background | Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24. |
| 28913915 | Background | Palm U, Kumpf U, Behler N, Wulf L, Kirsch B, Worsching J, Keeser D, Hasan A, Padberg F. Home Use, Remotely Supervised, and Remotely Controlled Transcranial Direct Current Stimulation: A Systematic Review of the Available Evidence. Neuromodulation. 2018 Jun;21(4):323-333. doi: 10.1111/ner.12686. Epub 2017 Sep 15. |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |