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NCT Number: NCT05326750

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

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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Key information

Conditions

Alzheimer Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Dementia With Lewy Bodies Frontotemporal Dementia Frontotemporal Lobar Degeneration Lewy Body Disease Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinsonian Disorders Proteostasis Deficiencies Synucleinopathies TDP-43 Proteinopathies Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, Finland

Location status: Recruiting

Location contact

Eino Solje

CONTACT

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Gamma tACS (40 Hz) over the superior parietal cortex

Device

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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)

  6. 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.

Secondary outcomes

  1. Change in SAI measurements

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

    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.

  2. Change in SICI measurements

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

    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.

  3. Change in ICF measurements

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eino Solje, MD, PhD

CONTACT

[email protected]

+358 17 713 311

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Apr 14, 2022
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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