Alzheimer DiseaseNCT03224988
Bilateral Brain Dynamics in Cognition and Aging
An observational study of Alzheimer Disease and Aging, run by Duke University at 1 site in United States.
Trial summary
This project is focused on the gap in understanding of bilateral brain interactions and their role in helping normative and clinical elderly populations maintain cognitive health. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Aging, MCI
- What is being tested?
- TMS
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 20 Jan 2022
- Phase
- Observational
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the Duke Bryan Alzheimer's Disease Research Center Alzheimer's Disease Prevention Registry (ADRC ADPR). Thirty healthy volunteers and thirty MCI-ADs will be recruited.
Who may be able to join
- Willing to provide informed consent
- English speaking
- Signed HIPAA authorization
- Use of effective method of birth control for women of childbearing capacity
Who cannot join
- Current or recent (within the past 6 months) of substance abuse or dependence, excluding nicotine and caffeine (urine test).
- Current serious medical illness (self report).
- History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by TMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator); [TMS Adult Safety Screening (TASS) form].
- Subjects are unable or unwilling to give informed consent.
- Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)
- Subjects with a clinically defined neurological disorder including, but not limited to:
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- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion.
- History of stroke.
- Transient ischemic attack within two years.
- Cerebral aneurysm.
- Dementia.
- Mini Mental Status Exam (MMSE) score of <24.
- Parkinson's disease.
- Huntington's disease.
- Multiple sclerosis.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold.
- Subjects not willing to tolerate the confinement associated with being in the MRI scanner.
- Women who are pregnant or breast-feeding (urine test).
- Blindness.
- Inability to read or understand English.
- Intracranial implants, such as:
- Cochlear implants;
- Aneurysms clips;
- Shunts;
- Stimulators;
- Electrodes;
- Cardiac pacemakers;
- Vagus Nerve stimulation devices.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: Bilateral Brain Dynamics Supporting Cognition in Normal Aging and Dementia
This project is focused on the gap in understanding of bilateral brain interactions and their role in helping normative and clinical elderly populations maintain cognitive health. The investigator will focus on investigating this neural mechanism of these interactions and promoting them with a precise application of TMS, in order to test the hypothesis that excitatory interactions between the hemispheres can provide positive outcomes for patients with pre-clinical AD (amnestic Mild Cognitive Impairment or MCI-AD). In Session 1, the investigator will establish the spatial specificity of bilateral brain mechanisms with combination of behavior, TMS, and structural neuroimaging in cortical sites known to be active during memory encoding. In Session 2, the investigator will establish the underlying dynamics of interhemispheric communication using a novel combination of TMS and electroencephalography (EEG) to establish the coordinated activity between the hemispheres; Lastly, in Session 3, the investigator will use the TMS entraining parameters delineated in Aim 2 to promote specific cross-hemispheric communication, applied to participants performing a Picture Encoding task, a general task of memory performance. The outcome of these studies will allow our group to evaluate the strength of this brain stimulation protocol in alleviating age-related and dementia-related cognitive decline, and enable development of novel treatment protocols for dementia in elderly cohorts.
- Conditions
- Alzheimer Disease, Aging, MCI
- Being tested
- TMS
- Keywords
- Alzheimer's Disease, AD, MCI-AD, MCI, Memory, TMS, Transcranial Magnetic Stimulation, Neuropsychological evaluation, MRI, DTI, EEG
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
A multimodal approach consisting of single pulse TMS, dual-coil TMS, and EEG will be used to examine whether synchronous hemispheric interactions associated with TMS will be present in weighted phase-lag coherence (WPLI), if these measures will be enhanced by in-phase TMS and reduced by counter-phase TMS, and if WPLI will be greater for normal controls than MCI-ADs.
| Study group | Role | What they receive |
|---|---|---|
| Normal Adults | Not described Receives: Device: TMS | |
| MCI Adults | Not described Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the structural basis for bilateral brain interactions in healthy older adults.
This will be examined using a Picture Encoding (PE) task in healthy older adults, which will allow identification of spatial brain targets based on the structural pathways connecting left and right DLPFC, ultimately relating the integrity of these pathways based on PE task performance. This Primary Outcome measure will therefore be performance scores (% correct) on this PE task.
Measured: 2 years
Establish the structural basis for bilateral brain interactions in MCI-AD older adults.
This will be examined using a Picture Encoding (PE) task in MCI-AD participants, which will allow identification of spatial brain targets based on the structural pathways connecting left and right DLPFC, ultimately relating the integrity of these pathways based on PE task performance. This Primary Outcome measure will therefore be performance scores (% correct) on this PE task.
Measured: 2 years
Secondary outcomes (6)
Establish the temporal dynamics of cross-hemispheric communication in normal aging using unilateral TMS
An approach consisting of single pulse will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Measured: 3 years
Establish the temporal dynamics of cross-hemispheric communication in normal aging using bilateral TMS
An approach consisting of dual-coil TMS will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Measured: 3 years
Establish the temporal dynamics of cross-hemispheric communication in normal aging using EEG
An approach consisting of EEG will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Measured: 3 years
Establish the temporal dynamics of cross-hemispheric communication in MCI-AD using unilateral TMS
An approach consisting of single pulse will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Measured: 3 years
Establish the temporal dynamics of cross-hemispheric communication in MCI-AD using bilateral TMS
An approach consisting of dual-coil TMS will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Measured: 3 years
Establish the temporal dynamics of cross-hemispheric communication in MCI-AD using EEG
An approach consisting of EEG will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start20 Mar 2018
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Simon Davis, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224988
- Sponsor's protocol ID
- Pro00085432
- Status last verified
- Feb 2022
- First submitted
- 10 Jul 2017
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Brain Dynamics Supporting Cognition in Normal Aging and Dementia
- ClinicalTrials.gov ID
- NCT03224988
- Acronym / sponsor ID
- Pro00085432
- Conditions
- Alzheimer Disease, Aging, MCI
- Keywords
- Alzheimer's Disease, AD, MCI-AD, MCI, Memory, TMS, Transcranial Magnetic Stimulation, Neuropsychological evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 21 Jul 2017 (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.
This project is focused on the gap in understanding of bilateral brain interactions and their role in helping normative and clinical elderly populations maintain cognitive health. The investigator will focus on investigating this neural mechanism of these interactions and promoting them with a precise application of TMS, in order to test the hypothesis that excitatory interactions between the hemispheres can provide positive outcomes for patients with pre-clinical AD (amnestic Mild Cognitive Impairment or MCI-AD). In Session 1, the investigator will establish the spatial specificity of bilateral brain mechanisms with combination of behavior, TMS, and structural neuroimaging in cortical sites known to be active during memory encoding. In Session 2, the investigator will establish the underlying dynamics of interhemispheric communication using a novel combination of TMS and electroencephalography (EEG) to establish the coordinated activity between the hemispheres; Lastly, in Session 3, the investigator will use the TMS entraining parameters delineated in Aim 2 to promote specific cross-hemispheric communication, applied to participants performing a Picture Encoding task, a general task of memory performance. The outcome of these studies will allow our group to evaluate the strength of this brain stimulation protocol in alleviating age-related and dementia-related cognitive decline, and enable development of novel treatment protocols for dementia in elderly cohorts.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Adults | – | Device: TMS |
| MCI Adults | – | Device: TMS |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the Duke Bryan Alzheimer's Disease Research Center Alzheimer's Disease Prevention Registry (ADRC ADPR). Thirty healthy volunteers and thirty MCI-ADs will be recruited.
Key inclusion criteria (4 listed)
- Willing to provide informed consent
- English speaking
- Signed HIPAA authorization
- Use of effective method of birth control for women of childbearing capacity
Key exclusion criteria (29 listed)
- Current or recent (within the past 6 months) of substance abuse or dependence, excluding nicotine and caffeine (urine test).
- Current serious medical illness (self report).
- History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by TMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator); [TMS Adult Safety Screening (TASS) form].
- Subjects are unable or unwilling to give informed consent.
- Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)
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 |
|---|---|---|
| TMSA multimodal approach consisting of single pulse TMS, dual-coil TMS, and EEG will be used to examine whether synchronous hemispheric interactions associated with TMS will be present in weighted phase-lag coherence (WPLI), if these measures will be enhanced by in-phase TMS and reduced by counter-phase TMS, and if WPLI will be greater for normal controls than MCI-ADs. | Device | MCI Adults, Normal Adults |
Primary outcome
Establish the structural basis for bilateral brain interactions in healthy older adults.
Time frame: 2 years
This will be examined using a Picture Encoding (PE) task in healthy older adults, which will allow identification of spatial brain targets based on the structural pathways connecting left and right DLPFC, ultimately relating the integrity of these pathways based on PE task performance. This Primary Outcome measure will therefore be performance scores (% correct) on this PE task.
Establish the structural basis for bilateral brain interactions in MCI-AD older adults.
Time frame: 2 years
This will be examined using a Picture Encoding (PE) task in MCI-AD participants, which will allow identification of spatial brain targets based on the structural pathways connecting left and right DLPFC, ultimately relating the integrity of these pathways based on PE task performance. This Primary Outcome measure will therefore be performance scores (% correct) on this PE task.
6 secondary outcomes
Establish the temporal dynamics of cross-hemispheric communication in normal aging using unilateral TMS
Time frame: 3 years
Establish the temporal dynamics of cross-hemispheric communication in normal aging using bilateral TMS
Time frame: 3 years
Establish the temporal dynamics of cross-hemispheric communication in normal aging using EEG
Time frame: 3 years
Establish the temporal dynamics of cross-hemispheric communication in MCI-AD using unilateral TMS
Time frame: 3 years
Establish the temporal dynamics of cross-hemispheric communication in MCI-AD using bilateral TMS
Time frame: 3 years
Establish the temporal dynamics of cross-hemispheric communication in MCI-AD using EEG
Time frame: 3 years
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 3 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Simon Davis, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Aging, run by Duke University at 1 site in United States.
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 4 inclusion and 29 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 3 Mar 2022. 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 United States. 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?
Establish the structural basis for bilateral brain interactions in healthy older adults. (time frame: 2 years). The study lists 2 primary outcomes in all. 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 3 Mar 2022.