Mild Cognitive ImpairmentNCT03647345
Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Mild Cognitive Impairment
A study testing High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC and High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC in people with Mild Cognitive Impairment, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of mild cognitive impairment (MCI) patients' cognitive function by altering the cortical excitability. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC and High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Apr 2015to 5 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild cognitive impairment diagnosed via a history, a neurocognitive test, and brain imaging
Who cannot join
- K-MMSE score under 9
- Major active neurological disease or psychiatric disease
- A history of seizure
- Metallic implants in their brain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation for Individualized Noninvasive Neuromodulation in Mild Cognitive Impairment
Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of mild cognitive impairment (MCI) patients' cognitive function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in MCI patients. In this study, simultaneous stimulation using both facilitatory rTMS (10Hz) and anodal or cathodal tDCS (dual-mode stimulation) over bilateral dorsolateral prefrontal cortices (DLPFCs) was investigated to compare its modulatory effects with single facilitatory rTMS stimulation in mild cognitive impairment patients.
- Conditions
- Mild Cognitive Impairment
- Being tested
- High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC, High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC, High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC
- Keywords
- Noninvasive brain stimulation, Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFCDevice
10Hz rTMS over the left DLPFC and anodal tDCS over the right DLPFC are simultaneously stimulated.
High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFCDevice
10Hz rTMS over the left DLPFC and cathodal tDCS over the right DLPFC are simultaneously stimulated.
High-frequency rTMS on left DLPFC+sham tDCS on right DLPFCDevice
10Hz rTMS over the left DLPFC and sham tDCS (no stimulation) over the right DLPFC are simultaneously stimulated.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1: Anodal Dual-mode stimulation | Experimental | 10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of anodal tDCS on the right DLPFC.
Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired. Receives: Device: High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC |
| Experimental 2: Cathodal Dual-mode stimulation | Experimental | 10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of cathodal tDCS on the right DLPFC.
Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired. Receives: Device: High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC |
| Active Comparator: Single sham stimulation | Active comparator | 10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of tDCS with sham mode (no stimulation) on the right DLPFC.
Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired. Receives: Device: High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of 2-back verbal working memory task
Accuracy (percentile) of 2-back verbal working memory task
Measured: Change from Pre-intervention at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start26 Apr 2015
- Primary completion5 Jul 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647345
- Sponsor's protocol ID
- 2015-01-132-005
- Status last verified
- Sep 2019
- First submitted
- 3 Jan 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation for Individualized Noninvasive Neuromodulation in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03647345
- Acronym / sponsor ID
- 2015-01-132-005
- Conditions
- Mild Cognitive Impairment
- Keywords
- Noninvasive brain stimulation, Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 26 Apr 2015 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of mild cognitive impairment (MCI) patients' cognitive function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in MCI patients. In this study, simultaneous stimulation using both facilitatory rTMS (10Hz) and anodal or cathodal tDCS (dual-mode stimulation) over bilateral dorsolateral prefrontal cortices (DLPFCs) was investigated to compare its modulatory effects with single facilitatory rTMS stimulation in mild cognitive impairment patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1: Anodal Dual-mode stimulation | Experimental | Device: High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of anodal tDCS on the right DLPFC. Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired. |
| Experimental 2: Cathodal Dual-mode stimulation | Experimental | Device: High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of cathodal tDCS on the right DLPFC. Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired. |
| Active Comparator: Single sham stimulation | Active comparator | Device: High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of tDCS with sham mode (no stimulation) on the right DLPFC. Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with mild cognitive impairment diagnosed via a history, a neurocognitive test, and brain imaging
Key exclusion criteria (4 listed)
- K-MMSE score under 9
- Major active neurological disease or psychiatric disease
- A history of seizure
- Metallic implants in their brain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC10Hz rTMS over the left DLPFC and anodal tDCS over the right DLPFC are simultaneously stimulated. | Device | Experimental 1: Anodal Dual-mode stimulation |
| High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC10Hz rTMS over the left DLPFC and cathodal tDCS over the right DLPFC are simultaneously stimulated. | Device | Experimental 2: Cathodal Dual-mode stimulation |
| High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC10Hz rTMS over the left DLPFC and sham tDCS (no stimulation) over the right DLPFC are simultaneously stimulated. | Device | Active Comparator: Single sham stimulation |
Primary outcome
Accuracy of 2-back verbal working memory task
Time frame: Change from Pre-intervention at 2 months
Accuracy (percentile) of 2-back verbal working memory task
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC and High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC in people with Mild Cognitive Impairment, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of 2-back verbal working memory task (time frame: Change from Pre-intervention at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.