Bilateral Brain Dynamics in Cognition and Aging



Status:Recruiting
Conditions:Alzheimer Disease, Healthy Studies
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:60 - 75
Updated:1/3/2019
Start Date:March 20, 2018
End Date:August 2020
Contact:Simon Davis, PhD
Email:simon.davis@duke.edu
Phone:919-684-1046

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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.


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.
We found this trial at
1
site
Durham, North Carolina 27705
Phone: 919-668-0437
?
mi
from
Durham, NC
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