Clinical trial NCT05326750: Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases
Official title: Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Frontotemporal Dementia
Dementia With Lewy Bodies
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Rey Auditory Verbal Learning Test score
timeFrame: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
measure: Changes in Rey Auditory Verbal Learning Test, recognition
timeFrame: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
measure: Changes in orientation to time and place (MMSE questions 1-10)
timeFrame: Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention
measure: Changes in Trail Making A & B tests
timeFrame: Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last intervention
measure: Changes in INECO Frontal Screening test
timeFrame: Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last intervention
measure: Changes in phonemic fluency
timeFrame: Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
Secondary outcomes:
measure: Change in SAI measurements
timeFrame: Baseline (immediately before the intervention), immediately after the last intervention
measure: Change in SICI measurements
timeFrame: Baseline (immediately before the intervention), immediately after the last intervention
measure: Change in ICF measurements
timeFrame: Baseline (immediately before the intervention), immediately after the last intervention
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Eino Solje, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: