Alzheimer DiseaseNCT05326750
Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases
A study testing Gamma tACS (40 Hz) over the superior parietal cortex in people with Alzheimer Disease and Frontotemporal Dementia, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tACS) in neurodegenerative diseases. The investigators will evaluate whether a 4-times daily repeated stimulation with gamma tACS on the posterior parietal cortex can improve symptoms in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Frontotemporal Dementia, Dementia With Lewy Bodies
- What is being tested?
- Gamma tACS (40 Hz) over the superior parietal cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 21 Nov 2022to Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild Cognitive Impairment due to Alzheimer's disease
- Dementia with Lewy Bodies
- Frontotemporal dementia
- Idiopathic normal pressure hydrocephalus (iNPH)
Who cannot join
- History of seizures
- Pregnancy
- Metal implants in the head (except dental fillings)
- Electronic implants (i.e. pace-maker, implanted medical pump)
- Age <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio
Eino Solje
About this study
Double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tACS) in neurodegenerative diseases. The investigators will evaluate whether a 4-times daily repeated stimulation with gamma tACS on the posterior parietal cortex can improve symptoms in patients with neurodegenerative diseases, including dementia with Lewy Bodies, Alzheimer's disease, idiopathic normal pressure hydrocephalus and Frontotemporal dementia.
Read the detailed description
Double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tACS) in neurodegenerative diseases. The investigators will evaluate whether a 4-times daily repeated stimulation with gamma tACS on the posterior parietal cortex can improve symptoms in patients with neurodegenerative diseases, including dementia with Lewy Bodies, Alzheimer's disease, idiopathic normal pressure hydrocephalus and Frontotemporal dementia.
- Being tested
- Gamma tACS (40 Hz) over the superior parietal cortex
- Medical subject headings
- Alzheimer Disease, Frontotemporal Dementia, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma tACS (40 Hz) over the superior parietal cortexDevice
Single session of gamma tACS (40 Hz) over the superior parietal cortex
| Study group | Role | What they receive |
|---|---|---|
| Real tACS | Experimental | Four sessions (once a day, during four consecutive days) of gamma tACS (40 Hz) at 3 mA over the superior parietal cortex (Precuneus) Receives: Device: Gamma tACS (40 Hz) over the superior parietal cortex |
| Sham tACS | Placebo comparator | Four sessions of sham tACS (once a day, during four consecutive days) over the superior parietal cortex (Precuneus) Receives: Device: Gamma tACS (40 Hz) over the superior parietal cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Rey Auditory Verbal Learning Test score
Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. Another list of 15 unrelated words are given and the patient must again repeat the original list of 15 words and then again after 30 minutes.
The examiner reads aloud 15 unrelated words and the participant is asked to recall the words after each of the five trials. After a 15 minute delay, the participant is asked again to recall the words. The score ranges from 0 (worst performance) to 75 (best performance).
Measured: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
Changes in Rey Auditory Verbal Learning Test, recognition
Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat.
After a 15 minute delay, the participant is asked to recognise the original 15 words intermixed with 31 distractor words. The score of the recognition part ranges from 0 (worst performance) to 46 (best performance).
Measured: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
Changes in orientation to time and place (MMSE questions 1-10)
10 questions about the orientation. The score ranges from 0 (worse performance) to 10 (best performance).
Measured: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
Changes in Trail Making A & B tests
TMT A \& B tests. Time to perform set is recorded.
Measured: Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last intervention
Changes in INECO Frontal Screening test
Test battery assessing frontal lobe functions. The score ranges from 0 (worse performance) to 30 (best performance)
Measured: Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last intervention
Changes in phonemic fluency
Person is requested to provide as many words as possible starting with certain letter. The score is the sum of all acceptable words produced in one minute.
Measured: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
Secondary outcomes (5)
Change in SAI measurements
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of gamma tACS on short latency afferent inhibition (SAI), which is a marker of cholinergic neurotransmission.
Measured: Baseline (immediately before the intervention), immediately after the last intervention
Change in SICI measurements
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of gamma tACS on short interval intracortical inhibition (SICI), which is a marker of gabaergic neurotransmission.
Measured: Baseline (immediately before the intervention), immediately after the last intervention
Change in ICF measurements
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of gamma tACS on intracortical facilitation (ICF), which is a marker of glutamatergic neurotransmission.
Measured: Baseline (immediately before the intervention), immediately after the last intervention
Change in modified Frontal Behavioral Inventory (FBI-mod) score
The modified Frontal Behavioral Inventory (FBI-mod) is used to assess behavioral symptoms associated with frontotemporal dysfunction. The questionnaire evaluates changes in behavioral and personality features. Higher scores indicate a greater severity of behavioral symptoms.
Measured: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
Change in Neuropsychiatric Inventory (NPI) score
The Neuropsychiatric Inventory (NPI) is used to assess neuropsychiatric symptoms, including their frequency and severity. Higher total scores indicate a greater burden of neuropsychiatric symptoms.
Measured: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start21 Nov 2022
- Primary completionJul 2032 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eino Solje, Kuopio University Hospital
- Investigators
- Eino Solje, MD, PhD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326750
- Sponsor's protocol ID
- KUH5772859
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized data upon request, according to Finnish national and EU GDPR regulations
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT05326750
- Acronym / sponsor ID
- KUH5772859
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- Jul 2032 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tACS) in neurodegenerative diseases. The investigators will evaluate whether a 4-times daily repeated stimulation with gamma tACS on the posterior parietal cortex can improve symptoms in patients with neurodegenerative diseases, including dementia with Lewy Bodies, Alzheimer's disease, idiopathic normal pressure hydrocephalus and Frontotemporal dementia.
Detailed description
Double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tACS) in neurodegenerative diseases. The investigators will evaluate whether a 4-times daily repeated stimulation with gamma tACS on the posterior parietal cortex can improve symptoms in patients with neurodegenerative diseases, including dementia with Lewy Bodies, Alzheimer's disease, idiopathic normal pressure hydrocephalus and Frontotemporal dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tACS | Experimental | Device: Gamma tACS (40 Hz) over the superior parietal cortexFour sessions (once a day, during four consecutive days) of gamma tACS (40 Hz) at 3 mA over the superior parietal cortex (Precuneus) |
| Sham tACS | Placebo comparator | Device: Gamma tACS (40 Hz) over the superior parietal cortexFour sessions of sham tACS (once a day, during four consecutive days) over the superior parietal cortex (Precuneus) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild Cognitive Impairment due to Alzheimer's disease
- Dementia with Lewy Bodies
- Frontotemporal dementia
- Idiopathic normal pressure hydrocephalus (iNPH)
Key exclusion criteria (5 listed)
- History of seizures
- Pregnancy
- Metal implants in the head (except dental fillings)
- Electronic implants (i.e. pace-maker, implanted medical pump)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamma tACS (40 Hz) over the superior parietal cortexSingle session of gamma tACS (40 Hz) over the superior parietal cortex | Device | Real tACS, Sham tACS |
Primary outcome
Changes in Rey Auditory Verbal Learning Test score
Time frame: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. Another list of 15 unrelated words are given and the patient must again repeat the original list of 15 words and then again after 30 minutes. The examiner reads aloud 15 unrelated words and the participant is asked to recall the words after each of the five trials. After a 15 minute delay, the participant is asked again to recall the words. The score ranges from 0 (worst performance) to 75 (best performance).
Changes in Rey Auditory Verbal Learning Test, recognition
Time frame: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. After a 15 minute delay, the participant is asked to recognise the original 15 words intermixed with 31 distractor words. The score of the recognition part ranges from 0 (worst performance) to 46 (best performance).
Changes in orientation to time and place (MMSE questions 1-10)
Time frame: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
10 questions about the orientation. The score ranges from 0 (worse performance) to 10 (best performance).
Changes in Trail Making A & B tests
Time frame: Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last intervention
TMT A \& B tests. Time to perform set is recorded.
Changes in INECO Frontal Screening test
Time frame: Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last intervention
Test battery assessing frontal lobe functions. The score ranges from 0 (worse performance) to 30 (best performance)
Changes in phonemic fluency
Time frame: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
Person is requested to provide as many words as possible starting with certain letter. The score is the sum of all acceptable words produced in one minute.
5 secondary outcomes
Change in SAI measurements
Time frame: Baseline (immediately before the intervention), immediately after the last intervention
Change in SICI measurements
Time frame: Baseline (immediately before the intervention), immediately after the last intervention
Change in ICF measurements
Time frame: Baseline (immediately before the intervention), immediately after the last intervention
Change in modified Frontal Behavioral Inventory (FBI-mod) score
Time frame: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
Change in Neuropsychiatric Inventory (NPI) score
Time frame: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. Pseudonymized data upon request, according to Finnish national and EU GDPR regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eino Solje, MD, PhD principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma tACS (40 Hz) over the superior parietal cortex in people with Alzheimer Disease and Frontotemporal Dementia, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eino Solje, MD, PhD (+358 17 713 311, eino.solje@uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Rey Auditory Verbal Learning Test score (time frame: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.