Status:
TERMINATED
Influence of Repetitive Transcranial Magnetic Stimulation (rTMS) Challenge on Cognitive and Functional Magnetic Resonance Imaging Markers in Healthy Subjects
Lead Sponsor:
Qualissima
Collaborating Sponsors:
Pharmacog's project (IMI)
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
NA
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) ...
Detailed Description
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) ...
Eligibility Criteria
Inclusion
- 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
- The subject have provided written informed consent
Exclusion
- 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.
- 4\. 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01490021
Start Date
December 1 2011
End Date
December 1 2012
Last Update
May 15 2013
Active Locations (1)
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1
IDIBAPS
Barcelona, Spain