Facilitating Associative Memory Via Deep Transcranial Magnetic Stimulation to the Medial Temporal Lobe

NCT01599208 | Withdrawn Early Phase 1 DMC

• 1 other identifier: TMS-MEMORY-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of the proposed research is to map the effects-in particular facilitation-of Transcranial Magnetic Stimulation (TMS) of the Medial Temporal Lobes (MTL) onto the processing of associative memory. TMS technology has the potential to selectively enhance functions mediated by areas in the temporal cortex, including the MTL, known to be the primary neuronal seat of episodic memory. By using this technology the investigators can further our understanding of theoretical models of human memory (specifically regarding the role of Recollection and Familiarity processes), and additionally, provide a possible route to the recovery of some of memory loss typically observed in the elderly-namely, memory for associations. Given the MTL's critical role in human memory and facilitation-inducing qualities of TMS, this research goal is to provide a nonintrusive tool to facilitate memory performance in young and elderly healthy participants.

Conditions

Effect of Deep Transcranial Magnetic Stimulation on Memory

Outcome Measures

Primary Outcomes (1)

• Change in memory based on the timeframe of the online stimulation

  For the online stimulation arms, we expect to find a change in memory based on the timeframe of the online stimulation and the cognitive task, namely, we expect to find change in memory for associations when stimulation is at around 800ms, and expect a change in memory for items when stimulation is at around 400ms.

  One year

Study Arms (6)

Single-pulse online stimulation

EXPERIMENTAL

Online single-pulse online stimulation at 120% of motor threshold to either the right or left MTL, in comparison to sham condition, in either -400/0/400/800 ms relatively to stimulus in either the study or test phases of a recognition test.

Device: TMS

Repetitive online stim., 400ms, 10Hz

EXPERIMENTAL

Repetitive online stimulation for 400ms at 10Hz at 120% of motor threshold to either the right or left MTL, in comparison to sham condition, in either -400/0/400/800 ms relatively to stimulus in either the study or test phases of a recognition test.

Device: TMS

Repetitive online stim., 400ms, 20Hz

EXPERIMENTAL

Repetitive online stimulation for 400ms at 20Hz at 120% of motor threshold to either the right or left MTL, in comparison to sham condition, in either -400/0/400/800 ms relatively to stimulus in either the study or test phases of a recognition test.

Device: TMS

Repetitive offline stimulation at 10Hz

EXPERIMENTAL

Repetitive offline stimulation at 10Hz for 4 min before study or for 8 min before test (in accordance with the phase length), comprising 2-second stimulation trains and 20-second breaks. Stimulation will be given at 120% of motor threshold to either the right or the left MTL in comparison to sham condition.

Device: TMS

Repetitive offline stimulation at 20Hz

EXPERIMENTAL

Repetitive offline stimulation at 20Hz for 4 min before study or for 8 min before test (in accordance with the phase length), comprising 2-second stimulation trains and 20-second breaks. Stimulation will be given at 120% of motor threshold to either the right or the left MTL in comparison to sham condition.

Device: TMS

Repetitive offline stimulation with iTBS

EXPERIMENTAL

Repetitive offline stimulation with Intermittent Theta Burst Stimulation (iTBS) comprising 3 pulses at 50Hz, repeated at 5Hz for 2-second stimulation trains with 8-second breaks for 192 seconds. Stimulation will be given at 90% of motor threshold to either the right or the left MTL in comparison to sham condition.

Device: TMS

Interventions

TMS DEVICE

TRANSCRANIAL MAGNETIC STIMULATION

Repetitive offline stimulation at 10Hz; Repetitive offline stimulation at 20Hz; Repetitive offline stimulation with iTBS; Repetitive online stim., 400ms, 10Hz; Repetitive online stim., 400ms, 20Hz; Single-pulse online stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women aged 18-85
• Answered negatively on safety screening questionnaire for TMS
• Capable and willing to provide informed consent.
• For participants aged more than 65, normal memory scoring should be obtained in a Nexig test.

You may not qualify if:

• History of epilepsy or seizure or history of such in first degree relatives.
• Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
• History of head injury necessitating cranial surgery or prolonged coma.
• History of any metal in the head including the eyes and ears (outside the mouth).
• Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
• History of severe migraine.
• History of significant hearing loss.
• Individuals with a significant neurological disorder.
• History of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine)
• Inadequate communication with the participant.
• Participation currently in another clinical study or enrolled in another clinical study within 30 days prior to this study.
• Participants who suffer from an unstable physical, systemic and metabolic disorders
• Women who are breast-feeding
• Known or suspected pregnancy

Sponsors & Collaborators

• Brainsway: lead

Study Officials

• Yonatan Goshen, Prof.

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 15, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 25, 2018

Record last verified: 2018-01