Influence of Repetitive Transcranial Magnetic Stimulation (rTMS) Challenge on Cognitive and Functional Magnetic Resonance Imaging Markers in Healthy Subjects

NCT01490021 | Terminated

• 1 other identifier: WP1P002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Episodic and working memory processes are the most affected cognitive domains in Alzheimer's Disease (AD) and its early stage, Mild Cognitive Impairment (MCI). Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing "virtual and transient lesions", mimicking those observed in MCI. It has proven repeatedly its capacity to interfere with encoding-retrieval memory task. However, to date, only few imaging data exist on the cerebral pathways involved in encoding memory task. Moreover, the stability of TMS effects over time remains to be investigated. If proven to be a stable interfering challenge, TMS could be used to investigate the potential restoring effect of new medication in AD. The study is the pilot study of a larger clinical trial which aims to prove the utility of rTMS as a potential model for prediction of clinical efficacy using a combination of cognitive and neuroimaging endpoints.

Conditions

Healthy

Keywords

Healthy young men

Outcome Measures

Primary Outcomes (2)

• Part A: Location of cerebral activities

  Primary endpoints: The location of cerebral activities elicited by the retrieval session of the episodic memory task during fMRI will be the primary endpoint of PART A. PART A will assess task-elicited BOLD signal modifications and determine the target location coordinates and verify the stability of the BOLD signal responses over time and the stability of the target location

  Day 1

• Part B: Outputs of the memory task

  Outputs: the number of correct answers during the retrieval blocks (Hit rates)and the number of false recognition of novel pictures (False Alarms rate).

  Change between Day 2 and Day 1

Secondary Outcomes (2)

• Part A: The outputs of the memory task

  Day 1 and Day 2

• Part B: Imaging and CANTAB tasks

  Day 1, 2, 3 and 4

Study Arms (2)

rTMS/Active TBS

EXPERIMENTAL

A continuous Theta-Burst Stimulation (TBS) protocol will be applied over the left dorsolateral prefrontal cortex. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec (Galea et al., 2010; Oberman and Pascual-Leone, 2009).

Procedure: rTMS/Active TBS

rTMS/Placebo TBS

PLACEBO COMPARATOR

rTMS/Placebo TBS

Procedure: rTMS/Placebo TBS

Interventions

rTMS/Active TBS PROCEDURE

A continuous Theta-Burst Stimulation (TBS) protocol will be applied over the left dorsolateral prefrontal cortex. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec (Galea et al., 2010; Oberman and Pascual-Leone, 2009).

rTMS/Active TBS

rTMS/Placebo TBS PROCEDURE

rTMS/Placebo TBS

rTMS/Placebo TBS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Demography
• Healthy male subjects aged between 18 and 40 years-old inclusive.
• BMI between 18 kg/m2 to 29 kg/m2.
• Education level: at least secondary.
• Right-handed (Edinburgh Handedness Inventory).
• Health status
• The subjects is in good health on the basis of the medical interview (medical history, symptoms) and the physical examination, vital signs.
• No history of psychiatric or neurological disorders as assessed by Structured Clinical Interview for DSM IV Disorders (SCID).
• No history of concussion with loss of consciousness more than 20 min.
• No history of drug or alcohol abuse.
• Specific to the study
• The subject can complete the neuropsychological test battery during the training session.
• Regulations
• The subject is able to read and understand the Information Form and comply with the protocol instructions and restrictions
• The subject is covered by a social insurance

You may not qualify if:

• Medical history and clinical status
• History or presence of psychiatric illness (Psychiatric interview).
• History or presence of neurologic illness.
• General conditions 3. The subject, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
• \. The subject participates in another clinical trial or is still being within a washout period of 1 month since last taking of a previous clinical trial, or subjects who have received more than 4500 Euros in the previous 12 months for participating in clinical trials.
• Specific to the study 5. Presence of metallic objects within the head. 6. Subjects with pacemaker. 7. Claustrophobia. 8. Individual and familial history of seizure. 9. Any medication listed in the safety guidelines published by the Safety of TMS Consensus Group (Rossi et al., 2009) will be forbidden.

Sponsors & Collaborators

• Qualissima: lead
• Pharmacog's project (IMI): collaborator

Study Sites (1)

IDIBAPS

Barcelona, Spain

Location

Study Officials

• David Bartrés-Faz

  Institut d'Investigacions Biomèdiques August Pi i Sunyer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 12, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

ES (1)