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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05326750
Other study ID # KUH5772859
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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