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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326750
• Other study ID #: KUH5772859
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: July 2032

Study information

• Verified date: January 2024
• Source: Kuopio University Hospital
• Contact: Eino Solje, MD, PhD
• Phone: +358 17 713 311
• Email: eino.solje[@]uef.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2032
• Est. primary completion date: July 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Dementia
• Dementia With Lewy Bodies
• Frontotemporal Dementia
• Lewy Body Disease
• Neurodegenerative Diseases
• Pick Disease of the Brain

Intervention

Device:
• Gamma tACS (40 Hz) over the superior parietal cortex
Single session of gamma tACS (40 Hz) over the superior parietal cortex

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in SAI measurements	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.	Baseline (immediately before the intervention), immediately after the last intervention
Secondary	Change in SICI measurements	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.	Baseline (immediately before the intervention), immediately after the last intervention
Secondary	Change in ICF measurements	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.	Baseline (immediately before the intervention), immediately after the last intervention