Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases
- Conditions
- Dementia With Lewy BodiesFrontotemporal DementiaAlzheimer Disease
- Interventions
- Device: Gamma tACS (40 Hz) over the superior parietal cortex
- Registration Number
- NCT05326750
- Lead Sponsor
- Kuopio University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Mild Cognitive Impairment due to Alzheimer's disease
- Dementia with Lewy Bodies
- Frontotemporal dementia
- Idiopathic normal pressure hydrocephalus (iNPH)
- History of seizures
- Pregnancy
- Metal implants in the head (except dental fillings)
- Electronic implants (i.e. pace-maker, implanted medical pump)
- Age <18 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Real tACS Gamma tACS (40 Hz) over the superior parietal cortex Four sessions (once a day, during four consecutive days) of gamma tACS (40 Hz) at 3 mA over the superior parietal cortex (Precuneus) Sham tACS Gamma tACS (40 Hz) over the superior parietal cortex Four sessions of sham tACS (once a day, during four consecutive days) over the superior parietal cortex (Precuneus)
- Primary Outcome Measures
Name Time Method Changes in Rey Auditory Verbal Learning Test score 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).Changes in Rey Auditory Verbal Learning Test, recognition 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).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 intervention 10 questions about the orientation. The score ranges from 0 (worse performance) to 10 (best performance).
Changes in Trail Making A & B tests 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.
Changes in INECO Frontal Screening test 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)
Changes in phonemic fluency 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 Outcome Measures
Name Time Method Change in SAI measurements 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.
Change in SICI measurements 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.
Change in ICF measurements 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.
Trial Locations
- Locations (1)
Kuopio University Hospital
🇫🇮Kuopio, Finland