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

Primary Purpose

Alzheimer Disease, Frontotemporal Dementia, Dementia With Lewy Bodies

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Gamma tACS (40 Hz) over the superior parietal cortex
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kuopio University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Real tACS

Sham tACS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).
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).
Changes in Trail Making A & B tests
TMT A & B tests. Time to perform set is recorded.
Changes in INECO Frontal Screening test
Test battery assessing frontal lobe functions. The score ranges from 0 (worse performance) to 30 (best performance)
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 23, 2022
Last Updated
November 22, 2022
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05326750
Brief Title
Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases
Official Title
Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
July 2032 (Anticipated)
Study Completion Date
July 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Frontotemporal Dementia, Dementia With Lewy Bodies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real tACS
Arm Type
Experimental
Arm Description
Four sessions (once a day, during four consecutive days) of gamma tACS (40 Hz) at 3 mA over the superior parietal cortex (Precuneus)
Arm Title
Sham tACS
Arm Type
Placebo Comparator
Arm Description
Four sessions of sham tACS (once a day, during four consecutive days) over the superior parietal cortex (Precuneus)
Intervention Type
Device
Intervention Name(s)
Gamma tACS (40 Hz) over the superior parietal cortex
Intervention Description
Single session of gamma tACS (40 Hz) over the superior parietal cortex
Primary Outcome Measure Information:
Title
Changes in Rey Auditory Verbal Learning Test score
Description
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 intervention
Title
Changes in Rey Auditory Verbal Learning Test, recognition
Description
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 intervention
Title
Changes in orientation to time and place (MMSE questions 1-10)
Description
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 intervention
Title
Changes in Trail Making A & B tests
Description
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 intervention
Title
Changes in INECO Frontal Screening test
Description
Test battery assessing frontal lobe functions. The score ranges from 0 (worse performance) to 30 (best performance)
Time Frame
Baseline (immediately before the intervention), immediately after the 4th intervention, 4 weeks after the last intervention
Title
Changes in phonemic fluency
Description
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.
Time Frame
Baseline (immediately before the intervention), immediately after the first intervention, immediately after the 4th intervention, 4 weeks after the last intervention
Secondary Outcome Measure Information:
Title
Change in SAI measurements
Description
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 intervention
Title
Change in SICI measurements
Description
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 intervention
Title
Change in ICF measurements
Description
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 intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eino Solje, MD, PhD
Phone
+358 17 713 311
Email
eino.solje@uef.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eino Solje, MD, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eino Solje

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pseudonymized data upon request, according to Finnish national and EU GDPR regulations
IPD Sharing Time Frame
Data will be shared after the study completion indefinitely.
IPD Sharing Access Criteria
Reasonable request

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

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