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RecruitingNCT05326750Updated Oct 2, 2026

Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases

An interventional study of Gamma tACS (40 Hz) over the superior parietal cortex in Alzheimer Disease, Frontotemporal Dementia and Dementia With Lewy Bodies, sponsored by Kuopio University Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Kuopio University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2022; still recruiting 3 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Alzheimer Disease
  • Frontotemporal Dementia
  • Dementia With Lewy Bodies
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In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 200 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Kuopio University Hospital is the lead sponsor of 135 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Mild Cognitive Impairment due to Alzheimer's disease
  • Dementia with Lewy Bodies
  • Frontotemporal dementia
  • Idiopathic normal pressure hydrocephalus (iNPH)

Exclusion criteria

Exclusion Criteria:

  • History of seizures
  • Pregnancy
  • Metal implants in the head (except dental fillings)
  • Electronic implants (i.e. pace-maker, implanted medical pump)
  • Age \<18 years
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Real tACS

    Four sessions (once a day, during four consecutive days) of gamma tACS (40 Hz) at 3 mA over the superior parietal cortex (Precuneus)

    Device: Gamma tACS (40 Hz) over the superior parietal cortex

  • Placebo comparator
    Sham tACS

    Four sessions of sham tACS (once a day, during four consecutive days) over the superior parietal cortex (Precuneus)

    Device: Gamma tACS (40 Hz) over the superior parietal cortex

Interventions

  • DeviceGamma tACS (40 Hz) over the superior parietal cortex

    Single session of gamma tACS (40 Hz) over the superior parietal cortex

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention

  2. 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).

    Time frame: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention

  3. 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).

    Time frame: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention

  4. Changes in Trail Making A & B tests

    TMT A \& B tests. Time to perform set is recorded.

    Time frame: Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last intervention

  5. Changes in INECO Frontal Screening test

    Test battery assessing frontal lobe functions. The score ranges from 0 (worse performance) to 30 (best performance)

    Time frame: Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last intervention

  6. 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.

    Time frame: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention

Secondary outcomes

  1. 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.

    Time frame: Baseline (immediately before the intervention), immediately after the last intervention

  2. 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.

    Time frame: Baseline (immediately before the intervention), immediately after the last intervention

  3. 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.

    Time frame: Baseline (immediately before the intervention), immediately after the last intervention

  4. 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.

    Time frame: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention

  5. 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.

    Time frame: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Yes — Pseudonymized data upon request, according to Finnish national and EU GDPR regulations

Time frame: Data will be shared after the study completion indefinitely.

Access criteria: Reasonable request

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2022 (actual). Primary completion is estimated for Jul 2032, 116 months after the start.

Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 116 months is above that.

Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2022
First posted
Apr 14, 2022
StartActual
Nov 21, 2022
Primary completionEst.
Jul 2032
CompletionEst.
Jul 2032
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
2 added
What changed in the outcomes
  • AddedChange in modified Frontal Behavioral Inventory (FBI-mod) scoreTime frame: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
  • AddedChange in Neuropsychiatric Inventory (NPI) scoreTime frame: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Secondary outcomes 2 added
    What changed in the outcomes
    • AddedChange in modified Frontal Behavioral Inventory (FBI-mod) scoreTime frame: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
    • AddedChange in Neuropsychiatric Inventory (NPI) scoreTime frame: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT05326750
Responsible party
Eino Solje (MD PhD adj. prof., Kuopio University Hospital) — Principal investigator
First posted
Apr 14, 2022
Start date
Nov 21, 2022
Primary completion
Jul 2032 (estimated)
Completion
Jul 2032 (estimated)
Last update
Oct 2, 2026

Study contacts

Eino Solje, MD, PhD
Contact
eino.solje@uef.fi
+358 17 713 311
Eino Solje, MD, PhD
principal investigator · Kuopio University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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