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

NCT05326750 | Recruiting

• 1 other identifier: KUH5772859
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Frontotemporal Dementia; Dementia With Lewy Bodies

Outcome Measures

Primary Outcomes (6)

• 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).

  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).

  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).

  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.

  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)

  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.

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

Secondary Outcomes (3)

• Change in SAI measurements

  Baseline (immediately before the intervention), immediately after the last intervention

• Change in SICI measurements

  Baseline (immediately before the intervention), immediately after the last intervention

• Change in ICF measurements

  Baseline (immediately before the intervention), immediately after the last intervention

Study Arms (2)

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)

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)

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

Interventions

Gamma tACS (40 Hz) over the superior parietal cortex DEVICE

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

Real tACS; Sham tACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kuopio University Hospital: lead

Study Sites (1)

Kuopio University Hospital

Kuopio, Finland

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Frontotemporal Dementia; Lewy Body Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Eino Solje, MD, PhD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eino Solje, MD, PhD

CONTACT

+358 17 713 311; eino.solje@uef.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD adj. prof.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 14, 2022
• Study Start: November 21, 2022
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2032
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared after the study completion indefinitely.
• Access Criteria: Reasonable request

Locations

FI (1)