Modulation of Episodic Memory Using Theta Burst Stimulation (TBS)

NCT03406195 | Withdrawn DMC FDA Device

• 1 other identifier: Pro00086794
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the effect of white matter guided theta burst stimulation on episodic memory task performance in healthy older adults. The investigators aim to propagate the effect of theta burst stimulation from a superficial locus of stimulation (angular gyrus) to hippocampus and parahippocampal regions using white matter tract connection between these regions. Study activities and population group - for the study plans to recruit 20 healthy older adults who already have white matter scans acquired as part of another study performed by the Cabeza Lab at Duke University. Using tractography the exact site of stimulation on the cortical surface will be localized. An initial motor evoked potential (MEP) assessment will differentiate responders to theta burst stimulation from non responders. Responders will receive 1200 pulses of intermittent theta burst stimulation (iTBS) or sham stimulation to the angular gyrus while they perform the encoding portion of an episodic memory task. There after, they will perform retrieval piece of the task and data analysis will compare these performances.

Conditions

Aging

Keywords

transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Episodic memory retrieval task decision

  Four-choice decision (1- definitely there is a link, 2-probably there is a link, 3-probably there is no link, 4-definitely there is no link) in response to semantic link retrieval between 2 words

  40 minutes

Study Arms (1)

healthy older adults

EXPERIMENTAL

Healthy older adults who will receive TMS

Device: Transcranial magnetic stimulation (TMS)

Interventions

Transcranial magnetic stimulation (TMS) DEVICE

TMS paradigm called theta burst stimulation

healthy older adults

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy controls in the age group 60-80 years old
• No other Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 axis 1 diagnoses
• Willing to provide informed consent
• Structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) data available

You may not qualify if:

• Subjects are unable or unwilling to give informed consent
• Presence of any organic brain illness
• Presence or history of stroke, traumatic brain injury or head injury with loss of consciousness, transient ischemic attack (TIA), any diagnosed neurological disorder including but not limited to multiple sclerosis, Huntington's disease, Parkinson's disease, dementia or major neurocognitive disorder.
• Presence of cranial metal implants, structural brain lesion including but not limited to cerebral aneurysms.
• Presence of devices that may be affected by repetitive transcranial magnetic stimulation (rTMS) (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
• Current or recent (within the past 6 months) substance abuse or dependence, excluding nicotine and caffeine.
• Current serious medical illness
• History of seizure except those therapeutically induced by electroconvulsive therapy (ECT) (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives
• For subjects age \> 59 years, a total scaled score \< 8 on the Dementia Rating Scale-2.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (19)

• Trebbastoni A, Pichiorri F, D'Antonio F, Campanelli A, Onesti E, Ceccanti M, de Lena C, Inghilleri M. Altered Cortical Synaptic Plasticity in Response to 5-Hz Repetitive Transcranial Magnetic Stimulation as a New Electrophysiological Finding in Amnestic Mild Cognitive Impairment Converting to Alzheimer's Disease: Results from a 4-year Prospective Cohort Study. Front Aging Neurosci. 2016 Jan 12;7:253. doi: 10.3389/fnagi.2015.00253. eCollection 2015.

  PMID: 26793103 BACKGROUND

• Julkunen P, Jauhiainen AM, Westeren-Punnonen S, Pirinen E, Soininen H, Kononen M, Paakkonen A, Maatta S, Karhu J. Navigated TMS combined with EEG in mild cognitive impairment and Alzheimer's disease: a pilot study. J Neurosci Methods. 2008 Jul 30;172(2):270-6. doi: 10.1016/j.jneumeth.2008.04.021. Epub 2008 Apr 29.

  PMID: 18533272 BACKGROUND

• Elder GJ, Taylor JP. Transcranial magnetic stimulation and transcranial direct current stimulation: treatments for cognitive and neuropsychiatric symptoms in the neurodegenerative dementias? Alzheimers Res Ther. 2014 Nov 10;6(9):74. doi: 10.1186/s13195-014-0074-1. eCollection 2014.

  PMID: 25478032 BACKGROUND

• Drumond Marra HL, Myczkowski ML, Maia Memoria C, Arnaut D, Leite Ribeiro P, Sardinha Mansur CG, Lancelote Alberto R, Boura Bellini B, Alves Fernandes da Silva A, Tortella G, Ciampi de Andrade D, Teixeira MJ, Forlenza OV, Marcolin MA. Transcranial Magnetic Stimulation to Address Mild Cognitive Impairment in the Elderly: A Randomized Controlled Study. Behav Neurol. 2015;2015:287843. doi: 10.1155/2015/287843. Epub 2015 Jun 16.

  PMID: 26160997 BACKGROUND

• Wang JX, Rogers LM, Gross EZ, Ryals AJ, Dokucu ME, Brandstatt KL, Hermiller MS, Voss JL. Targeted enhancement of cortical-hippocampal brain networks and associative memory. Science. 2014 Aug 29;345(6200):1054-7. doi: 10.1126/science.1252900.

  PMID: 25170153 BACKGROUND

• Rushworth MF, Behrens TE, Johansen-Berg H. Connection patterns distinguish 3 regions of human parietal cortex. Cereb Cortex. 2006 Oct;16(10):1418-30. doi: 10.1093/cercor/bhj079. Epub 2005 Nov 23.

  PMID: 16306320 BACKGROUND

• Uddin LQ, Supekar K, Amin H, Rykhlevskaia E, Nguyen DA, Greicius MD, Menon V. Dissociable connectivity within human angular gyrus and intraparietal sulcus: evidence from functional and structural connectivity. Cereb Cortex. 2010 Nov;20(11):2636-46. doi: 10.1093/cercor/bhq011. Epub 2010 Feb 12.

  PMID: 20154013 BACKGROUND

• Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

  PMID: 15664172 BACKGROUND

• Wischnewski M, Schutter DJ. Efficacy and Time Course of Theta Burst Stimulation in Healthy Humans. Brain Stimul. 2015 Jul-Aug;8(4):685-92. doi: 10.1016/j.brs.2015.03.004. Epub 2015 Mar 26.

  PMID: 26014214 BACKGROUND

• Suppa A, Huang YZ, Funke K, Ridding MC, Cheeran B, Di Lazzaro V, Ziemann U, Rothwell JC. Ten Years of Theta Burst Stimulation in Humans: Established Knowledge, Unknowns and Prospects. Brain Stimul. 2016 May-Jun;9(3):323-335. doi: 10.1016/j.brs.2016.01.006. Epub 2016 Jan 27.

  PMID: 26947241 BACKGROUND

• Davis SW, Dennis NA, Buchler NG, White LE, Madden DJ, Cabeza R. Assessing the effects of age on long white matter tracts using diffusion tensor tractography. Neuroimage. 2009 Jun;46(2):530-41. doi: 10.1016/j.neuroimage.2009.01.068.

  PMID: 19385018 BACKGROUND

• Davis SW, Kragel JE, Madden DJ, Cabeza R. The architecture of cross-hemispheric communication in the aging brain: linking behavior to functional and structural connectivity. Cereb Cortex. 2012 Jan;22(1):232-42. doi: 10.1093/cercor/bhr123. Epub 2011 Jun 7.

  PMID: 21653286 BACKGROUND

• Kier EL, Staib LH, Davis LM, Bronen RA. MR imaging of the temporal stem: anatomic dissection tractography of the uncinate fasciculus, inferior occipitofrontal fasciculus, and Meyer's loop of the optic radiation. AJNR Am J Neuroradiol. 2004 May;25(5):677-91.

  PMID: 15140705 BACKGROUND

• Kier EL, Staib LH, Davis LM, Bronen RA. Anatomic dissection tractography: a new method for precise MR localization of white matter tracts. AJNR Am J Neuroradiol. 2004 May;25(5):670-6.

  PMID: 15140704 BACKGROUND

• Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f.

  PMID: 21221011 BACKGROUND

• Daselaar SM, Fleck MS, Dobbins IG, Madden DJ, Cabeza R. Effects of healthy aging on hippocampal and rhinal memory functions: an event-related fMRI study. Cereb Cortex. 2006 Dec;16(12):1771-82. doi: 10.1093/cercor/bhj112. Epub 2006 Jan 18.

  PMID: 16421332 BACKGROUND

• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

  PMID: 19833552 BACKGROUND

• Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8.

  PMID: 9474057 BACKGROUND

• Loo C, Sachdev P, Elsayed H, McDarmont B, Mitchell P, Wilkinson M, Parker G, Gandevia S. Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. Biol Psychiatry. 2001 Apr 1;49(7):615-23. doi: 10.1016/s0006-3223(00)00996-3.

  PMID: 11297719 BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Roberto Cabeza, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will perform episodic memory task before and after the TMS session

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 23, 2018
• Study Start: December 15, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

US (1)