Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02767323
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : October 6, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Duke University

Brief Summary:

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 rTMS to enhance working memory performance. This will be achieved through three Aims. In the first, registered on this record, the investigator will stimulate both old and young healthy adults while they perform the WM task that will engage the frontoparietal network. To define the optimal rTMS target, rTMS will be applied over the dorsolateral prefrontal cortex (DLPFC: Aim 1a); or over the parietal cortex (PC: Aim 1b). These regions are involved not only in the maintenance of items in WM, but also in their manipulation, therefore applying rTMS over these areas should create WM performance enhancements that will be long-lasting. In Aim 1c, a direct within-subject comparison of these 2 targeted sites is performed.

In the second and third Aims, older adults will receive active or sham rTMS over the optimal target (defined in Arm 1) during two weeks of daily sessions while they perform the WM tasks. In the second Aim, 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. The success of these 3 Aims 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. This record is a reflection of Aim1, Aim 2 and 3 will be registered separately.


Condition or disease Intervention/treatment Phase
Aging Device: rTMS Device: Sham rTMS Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
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
Actual Study Start Date : August 15, 2016
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : March 16, 2020

Arm Intervention/treatment
Active Comparator: rTMS over the DLPFC (Aim1a)
excitatory rTMS applied over the DLPFC (fMRI-guided)
Device: rTMS
excitatory 5Hz rTMS will be used

Sham Comparator: Sham rTMS over the DLPFC (Aim1a)
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

Active Comparator: rTMS over the Parietal cortex (Aim1b)
excitatory rTMS applied over the parietal cortex (fMRI-guided)
Device: rTMS
excitatory 5Hz rTMS will be used

Sham Comparator: Sham rTMS over the Parietal cortex (Aim1b)
electrical sham coil applied over the parietal cortex (fMRI-guided)
Device: Sham rTMS
an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used

Active Comparator: rTMS over the DLPFC and the Parietal cortex (Aim 1c)
excitatory rTMS applied over the the DLPFC and the parietal cortex (fMRI-guided)
Device: rTMS
excitatory 5Hz rTMS will be used

Sham Comparator: Sham rTMS over the DLPFC and the Parietal cortex (Aim 1c)
electrical sham coil applied over the DLPFC and the parietal cortex (fMRI-guided)
Device: Sham rTMS
an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.

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


Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Lawrence Appelbaum Duke University
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02767323    
Other Study ID Numbers: Pro00065334
1R01AG050618-01 ( U.S. NIH Grant/Contract )
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No