- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03655769
fMRI Analysis of Aging and Awareness in Conditioning
Functional Magnetic Resonance Imaging (fMRI) Analysis of Aging and Awareness in Conditioning
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Educational attainment of at least eight years and English as the native language
- Mini-Mental State Examination (MMSE) score of 26
- Normal episodic memory (i.e., CERAD word List Recall > 5)
- Informed consent; 5) age of 20-30
Exclusion Criteria:
- Disturbed consciousness
- Other neurological or systemic disorder which can cause dementia or cognitive dysfunction
- Prior history of a major psychiatric disorder
- History of definite stroke
- Focal lesion on MRI exam
- Use of anxiolytic, antidepressant, neuroleptic, or sedative medication
- Predominately left-handed
- Has MRI contraindication such as pacemaker, implanted pumps, shrapnel, etc. (full MRI screening form will be filled out).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: sham tDCS
tDCS delivered for only 30 sec to replicate tingling sensation and blind subject
|
transcranial direct current stimulation applied at 2 mA over the right parietal region for 30 sec
|
|
Experimental: cathodal tDCS
cathodal tDCS, 2 milliamps (mA), delivered to right parietal region
|
transcranial direct current stimulation applied at 2 mA over the right parietal region for 20 min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CS-US Awareness
Time Frame: recorded immediately after the 20 minutes of tDCS stimulation
|
To assess CS-US awareness, we used a questionnaire The questionnaire consists of 7 true/false questions about the sequence and co-occurrence of the conditioned stimulus (CS, a 1000 Hz tone) and unconditioned stimulus (US, a 100 ms puff of air to the eye).
The score can thus range from 0 to 7. Higher score values indicate better awareness of the sequence and co-occurrence of the CS and US
|
recorded immediately after the 20 minutes of tDCS stimulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Line bisection test of left-hemifield neglect
Time Frame: recorded immediately after primary awareness questionnaire
|
The subject is given a sheet of paper with a number of horizontal lines on it. The subject is instructed to cut each line in half by drawing a small pencil mark through each line. The test is scored by measuring the percent deviation, which is calculated by the following formula: Percent deviation=100 x (measured left half - true half)/true half This yields positive numbers for marks placed to the right of center, and negative numbers for marks placed to the left of center. Patients with right hemisphere damage and contralateral neglect show higher positive line bisection scores compared to healthy controls or patients without right hemisphere damage and vice versa. |
recorded immediately after primary awareness questionnaire
|
|
Eyeblink conditioned responding
Time Frame: recorded during the tDCS administration
|
Eyeblink conditioning is recorded while the subject watches a silent movie.
For conditioning, the conditioned stimulus (CS) is a 1350 ms 1000 Hz tone.
This tone co-terminates with a 100 ms left corneal airpuff (5 psi).
30 CS-US presentations are delivered at an average rate of one every 18 sec.
Conditioned responses (CRs) are defined as follows: the difference between the maximum and minimum responses in a 500 ms pre-US time window must exceed four times the standard deviation of the mean of the baseline period (250 ms pre-CS presentation).
The 500 ms pre-US time window was selected to minimize the inclusion of voluntary and alpha responses as CRs.
Performance is expressed as % CRs, that is, the percent of trials in which a CR occurred.
Greater numbers indicate greater amounts of learning.
|
recorded during the tDCS administration
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John Desmond, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00045404
- R01AG021501 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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