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Effects of rTMS on Impulsivity and Empathy

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: NCT03200873
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
Impulsivity describes the tendency to make risky and unplanned decisions, to pick immediate reward over a bigger reward after a period of time or to not be able to resist the urge to do something. Empathy refers to the ability to be sensitive to and vicariously experience other people's feelings and to create working models of emotional states. Recent neuroscientific research have found that the right frontal part of the brain (left dorsal lateral frontal cortex, LDLPFC) is important in the control of impulsive behaviour and empathy. Self-report questionnaires have been proven valid measures at assessing impulsivity and empathy. Repetitive Transcranial Magnetic Stimulation (rTMS) is a widely used non-invasive brain stimulation procedure; stimulation can be applied at different brain regions depending on the administration method. It temporally changes the way that this part of the brain functions, providing us a further understanding of how this part works. Recent research has found that rTMS on the LDLPFC changes performance-based tasks measuring different types of impulsivity and empathy. This study aims to investigate this further to look at the RDLPFC stimulation and its effects on empathy and two different types of impulsivity. Of interest is also how innate impulsive personality type and empathy trait relate to performance on these tasks.

Condition or disease Intervention/treatment Phase
Impulsive Behavior Empathy Device: repetitive transcranial magnetic stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: crossover (real and sham stimulation) design with randomised allocation of outcome examination
Masking: Single (Participant)
Masking Description: using a shall coil to mimic the active stimulation
Primary Purpose: Treatment
Official Title: Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Impulsivity and Empathy in a Non-clinical Population
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017

Arm Intervention/treatment
Active Comparator: high impulsivity
participants with high impulsivity (BIS >62), receiving active and sham repetitive transcranial magnetic stimulation [intermittent theta burst stimulation (iTBS)] in a randomised order
Device: repetitive transcranial magnetic stimulation
Each session of iTBS will apply3 trains of 600 pulses to the RDLPFC, with 20 2-second trains and an 8-second inter-train interval. Sham iTBS condition will be administered with the same methodology used for active iTBS condition with a sham coil mimicking noises and vibrations without delivery of magnetic pulses.
Other Name: intermittent theta burst stimulation

Active Comparator: low impulsivity
participants with low impulsivity (BIS between 52 to 62), receiving active and sham repetitive transcranial magnetic stimulation [intermittent theta burst stimulation (iTBS)] in a randomised order
Device: repetitive transcranial magnetic stimulation
Each session of iTBS will apply3 trains of 600 pulses to the RDLPFC, with 20 2-second trains and an 8-second inter-train interval. Sham iTBS condition will be administered with the same methodology used for active iTBS condition with a sham coil mimicking noises and vibrations without delivery of magnetic pulses.
Other Name: intermittent theta burst stimulation




Primary Outcome Measures :
  1. Impulsivity (performance-based) [ Time Frame: (usually 20 mins apart) the time just before rTMS and right after rTMS (usually 20 mins apart) ]
    P(correct) from IST and K value from AAT

  2. empathy (performance-based) [ Time Frame: baseline and right after rTMS (usually 20 mins apart) ]
    correct scores from RMET


Secondary Outcome Measures :
  1. Correlation between self-reported and performance-based impulsivity [ Time Frame: baseline ]
    correlation coefficient between [P(correct)], K value and AUC and UPPS-P and BIS-11

  2. Correlation between self-reported and performance-based empathy [ Time Frame: baseline ]
    correlation coefficient between RMET correct score and QCAE


Other Outcome Measures:
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: through study completion, an average within 1 week ]
    The frequency of adverse events from each participant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males predominantly have higher impulsivity level compared to females
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male students or staff in University of Nottingham
  • aged 18-30 years.
  • normal or corrected-to-normal vision
  • BIS-11 scored above 71 or between 52 to 62
  • Ability to give informed consent

Exclusion Criteria:

  • Have ever suffered an epileptic fit
  • Have had a brain injury or neurological disorder
  • Have any non-removable metal implants in your head
  • Have a family history of brain injury or epilepsy
  • Drink more than 20 units of alcohol per week on a regular basis
  • Currently take any illicit drugs
  • Ever were dependent on illicit drugs or alcohol
  • Ever suffered from a serious mental illness such as schizophrenia, severe depression or bipolar disorder
  • Currently take any psychiatric medication

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): NCT03200873


Locations
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United Kingdom
Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2TU
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Birgit Völlm, PhD Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03200873    
Other Study ID Numbers: C200317
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Nottingham:
transcranial magnetic stimulation
theta burst stimulation
impulsivity
Additional relevant MeSH terms:
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Impulsive Behavior