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

Kuopio University Hospital

Status: Enrolling

Conditions: Alzheimer Disease; Frontotemporal Dementia; Dementia With Lewy Bodies

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05326750

KUH5772859

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Real tACS

Experimental group

Description:

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

Treatment:

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

Sham tACS

Placebo Comparator group

Description:

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

Treatment:

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