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Trial record 2 of 20 for:    Duke Dementia | Recruiting, Not yet recruiting, Available Studies

Using TMS to Increase Executive Function in Older Adults (WMTMS)

This study is currently recruiting participants.
Verified March 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02767323
First Posted: May 10, 2016
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Duke University
  Purpose
Cognitive decline and dementia have become important public health issues in our time as medical science has increased lifespan and our society becomes progressively older. A great deal of the cognitive decline due to aging can be explained by decline in working memory (WM), a mental function central to cognition in which aging deficits appear almost universally. Attempts to use WM training to increase WM ability in older adults has had some success, but the transfer of performance enhancements caused by this training to other cognitive skills is controversial. Another intervention that shows much promise is noninvasive stimulation of cerebral cortex using transcranial magnetic stimulation (TMS), which has been shown to increase performance in many cognitive tasks. Here, the investigator proposes to use fMRI-guided TMS enhancement paradigm to stimulate dorsolateral prefrontal cortex (DLPFC), a region involved not only in the maintenance of items in WM, but also in their manipulation, in order to create WM performance enhancements that will be long lasting and that will transfer to other cognitive tasks as well. This will be achieved through three studies. In the first the investigator will stimulate both old and young healthy adults while they perform different WM tasks that will increasingly engage DLPFC in order to demonstrate enhancement of WM performance that is greater in the older adults. In the second and third studies, older adults will receive active or sham TMS over two weeks of daily sessions while they perform the WM tasks. In the second study, the investigator hopes to demonstrate that the cumulative effect of multiple TMS sessions, in tandem with the synergistic effects of simultaneous TMS + WM training, create WM performance enhancements greater than those found with WM training alone, whose effects are long-lasting, continuing a month following the course of TMS sessions. In the third, the investigator will investigate whether the WM enhancements generated by the two weeks of TMS sessions will generalize to other cognitive tasks. Success of these studies will provide proof in principle for long-lasting, transferable effects of TMS in remediating WM and more general cognitive deficits due to aging, and point to a possible non-invasive brain stimulation therapy for cognitive decline in healthy aging and in dementia.

Condition Intervention
Aging Device: rTMS Device: Sham rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Using fMRI-guided TMS to Increase Central Executive Function in Older Adults

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Acute effect of a rTMS session on the performance for a working memory task, as measured by reaction time of correct response (in ms) [ Time Frame: During the rTMS session ]
    Reaction time of correct response (in ms) will be assessed to evaluate the acute effect of rTMS applied over the DLPFC

  • change in cumulative effects of rTMS on the performance for a working memory task, as measured by reaction time of correct response (in ms) [ Time Frame: baseline, two weeks ]
    Reaction time of correct response (in ms) will be assessed to evaluate the cumulative effects of rTMS applied over the DLPFC during two weeks

  • change in transfer of the effect of rTMS on other global cognition, as measured by reaction time of correct response (in ms) [ Time Frame: baseline, two weeks ]
    Reaction time of correct response (in ms) will also be assessed.

  • Acute effect of a rTMS session on the performance for a working memory task, as measured by accuracy (in percentage) [ Time Frame: During the rTMS session ]
    Accuracy (in percentage) will be assessed to evaluate the acute effect of rTMS applied over the DLPFC

  • change in cumulative effects of rTMS on the performance for a working memory task, as measured by accuracy (in percentage) [ Time Frame: baseline, two weeks ]
    Accuracy (in percentage) will be assessed to evaluate the cumulative effects of rTMS applied over the DLPFC during two weeks

  • change in transfer of the effect of rTMS on other global cognition, as measured by accuracy (in percentage) [ Time Frame: baseline, two weeks ]
    Accuracy (in percentage) will also be assessed.


Estimated Enrollment: 60
Study Start Date: January 2016
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: repetitive TMS
excitatory rTMS applied over the DLPFC (fMRI-guided)
Device: rTMS
excitatory 5Hz rTMS will be used
Sham Comparator: Sham repetitive TMS
electrical sham coil applied over the DLPFC (fMRI-guided)
Device: Sham rTMS
an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age Restrictions: Young Group (from 18 to 35 years old), Elderly Group (from 60 to 80 years old).
  • Use of effective method of birth control for women of childbearing capacity.
  • Willing to provide informed consent.

Exclusion Criteria:

  • Current or recent (within the past 6 months) history of substance abuse or dependence.
  • Current serious medical illness.
  • History of seizure, epilepsy, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
  • Inability or unwilling to give informed consent.
  • Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV).
  • For subjects age > 59 years, a total scaled score < 8 on the Dementia Rating Scale-2.
  • Clinically defined neurological disorder.
  • Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or currently taking medication that lowers the seizure threshold.
  • Claustrophobia (MRI scanner).
  • Pregnancy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767323


Contacts
Contact: Susan A Hilbig 9196845939 susan.hilbig@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Susan A Hilbig    919-684-8989    susan.hilbig@duke.edu   
Sponsors and Collaborators
Duke University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Lawrence Appelbaum Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02767323     History of Changes
Other Study ID Numbers: Pro00065334
1R01AG050618-01 ( U.S. NIH Grant/Contract )
First Submitted: May 5, 2016
First Posted: May 10, 2016
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided