Bilateral Brain Dynamics in Cognition and Aging

NCT ID: NCT03224988

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-20
• Study Completion Date: 2022-01-20

Brief 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. 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal Adults

TMS

Intervention Type: DEVICE

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.

MCI Adults

TMS

Intervention Type: DEVICE

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.

Interventions

TMS

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Willing to provide informed consent

2. English speaking

3. Signed HIPAA authorization

4. Use of effective method of birth control for women of childbearing capacity

Exclusion Criteria

1. Current or recent (within the past 6 months) of substance abuse or dependence, excluding nicotine and caffeine (urine test).

2. Current serious medical illness (self report).

3. 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].

4. Subjects are unable or unwilling to give informed consent.

5. Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)

6. Subjects with a clinically defined neurological disorder including, but not limited to:

1. Any condition likely to be associated with increased intracranial pressure

2. Space occupying brain lesion.

3. History of stroke.

4. Transient ischemic attack within two years.

5. Cerebral aneurysm.

6. Dementia.

7. Mini Mental Status Exam (MMSE) score of <24.

8. Parkinson's disease.

9. Huntington's disease.

i. Multiple sclerosis.

7. 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.

8. Subjects not willing to tolerate the confinement associated with being in the MRI scanner.

9. Women who are pregnant or breast-feeding (urine test).

10. Blindness.

11. Inability to read or understand English.

12. Intracranial implants, such as:

1. Cochlear implants;

2. Aneurysms clips;

3. Shunts;

4. Stimulators;

5. Electrodes;

6. Cardiac pacemakers;

7. Vagus Nerve stimulation devices.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Hospital

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00085432

Identifier Type: -

Identifier Source: org_study_id