Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKuopio University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Mild Cognitive Impairment due to Alzheimer's disease
Dementia with Lewy Bodies
Frontotemporal dementia
Idiopathic normal pressure hydrocephalus (iNPH)
Disqualifiers
History of seizures
Pregnancy
Metal implants in the head (except dental fillings)
Electronic implants (i.e. pace-maker, implanted medical pump)
Trial design
Design model
Parallel
Treatments tested in this trial
Gamma tACS (40 Hz) over the superior parietal cortex
DeviceSingle session of gamma tACS (40 Hz) over the superior parietal cortex
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Real tACSExperimental treatment 1 intervention
Group B: Sham tACSPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention2
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).
Time frame
Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention3
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).
Time frame
Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last intervention4
Changes in Trail Making A & B tests
TMT A \& B tests. Time to perform set is recorded.
Time frame
Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last interventionSecondary outcomes
1
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.
Time frame
Baseline (immediately before the intervention), immediately after the last intervention2
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.
Time frame
Baseline (immediately before the intervention), immediately after the last intervention3
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.
Time frame
Baseline (immediately before the intervention), immediately after the last intervention4
Change in modified Frontal Behavioral Inventory (FBI-mod) score
The modified Frontal Behavioral Inventory (FBI-mod) is used to assess behavioral symptoms associated with frontotemporal dysfunction. The questionnaire evaluates changes in behavioral and personality features. Higher scores indicate a greater severity of behavioral symptoms.
Time frame
Baseline (immediately before the intervention), immediately after the last intervention, 4 weeks after the last interventionSponsors and contacts
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Source ClinicalTrials.gov