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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05326750
Enrollment
200
Registered
2022-04-14
Start date
2022-11-21
Completion date
2032-07-31
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Dementia With Lewy Bodies, Frontotemporal Dementia

Brief 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.

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.

Interventions

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

Sponsors

Kuopio University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in phonemic fluencyBaseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last interventionPerson 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.
Changes in orientation to time and place (MMSE questions 1-10)Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention10 questions about the orientation. The score ranges from 0 (worse performance) to 10 (best performance).
Changes in Trail Making A & B testsBaseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last interventionTMT A & B tests. Time to perform set is recorded.
Changes in INECO Frontal Screening testBaseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last interventionTest battery assessing frontal lobe functions. The score ranges from 0 (worse performance) to 30 (best performance)
Changes in Rey Auditory Verbal Learning Test scoreBaseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last interventionParticipants 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, recognitionBaseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last interventionParticipants 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).

Secondary

MeasureTime frameDescription
Change in SICI measurementsBaseline (immediately before the intervention), immediately after the last interventionBy 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.
Change in ICF measurementsBaseline (immediately before the intervention), immediately after the last interventionBy 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.
Change in SAI measurementsBaseline (immediately before the intervention), immediately after the last interventionBy 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.

Countries

Finland

Contacts

Primary ContactEino Solje, MD, PhD
eino.solje@uef.fi+358 17 713 311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026