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Effects of rTMS on Impulsivity and Empathy

Primary Purpose

Impulsive Behavior, Empathy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impulsive Behavior focused on measuring transcranial magnetic stimulation, theta burst stimulation, impulsivity

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

high impulsivity

low impulsivity

Arm Description

participants with high impulsivity (BIS >62), receiving active and sham repetitive transcranial magnetic stimulation [intermittent theta burst stimulation (iTBS)] in a randomised order

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

Outcomes

Primary Outcome Measures

Impulsivity (performance-based)
P(correct) from IST and K value from AAT
empathy (performance-based)
correct scores from RMET

Secondary Outcome Measures

Correlation between self-reported and performance-based impulsivity
correlation coefficient between [P(correct)], K value and AUC and UPPS-P and BIS-11
Correlation between self-reported and performance-based empathy
correlation coefficient between RMET correct score and QCAE

Full Information

First Posted
June 13, 2017
Last Updated
May 1, 2018
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT03200873
Brief Title
Effects of rTMS on Impulsivity and Empathy
Official Title
Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Impulsivity and Empathy in a Non-clinical Population
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Background Impulsivity describes the tendency to make risky and unplanned decisions, to pick immediate reward over a bigger reward after a period 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 left frontal part of the brain (left dorsal lateral frontal cortex, RDLPFC) 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 LDLPFC stimulation using the newer form of high-frequency rTMS, intermittent theta burst stimulation (iTBS) 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. Aims The specific purposes of this study are to (i) examine whether iTBS is an effective technique for modulating impulsivity and empathy, and to (ii) examine the relationship between the modulatory effects of the iTBS and baseline self-reported impulsivity and empathy. The key objectives of this study are to examine whether the specific iTBS protocol at RDLPFC can effectively modulate two subtypes of impulsivity (delayed discounting and reflection impulsivity) and empathy, and to examine whether the participant's baseline self-reported impulsivity and empathy scores mediate the modulatory effects of the iTBS on impulsivity and empathy respectively in normal healthy young adults. The secondary objectives of this study are to examine whether the self-reported measures of impulsivity and empathy correlate with their performance-based counterparts. Experimental protocol and methods The proposed study will be a single-centre, crossover design study, taking place at Queens Medical Centre, Nottinghamshire NHS Trust. Participants (male students or staff) will be recruited from the University of Nottingham. A potential participant will be asked to complete the TMS screening questionnaire to ensure that there are no contraindications to using TMS. After the written informed consent is obtained, he will then be asked to complete an online questionnaire (Barratt Impulsiveness Scale -version 11, BIS-11) measuring self-report impulsivity. The scores obtained from BIS-11 will be one of the screening criteria. If the potential participant is eligible for taking part in the study, he will be invited to the two laboratory sessions. He will then be asked to perform three computerised tasks assessing impulsivity and empathy before and after the iTBS administration. Each session of iTBS will apply 600 pulses to the LDLPFC, with 20 2-second trains and an 8-second inter-train interval for a total stimulation time of 190 seconds. 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. Participants will be asked to guess which rTMS condition is real after completing the whole study to ascertain that whether the sham manipulation is successful or not. Participants will be monitored if they experience any adverse events during the rTMS session and instructed to report any experience of adverse events after each rTMS session. Tolerability will be presented as the number of reported adverse events and the number of dropouts due to adverse events. Measurable end points/statistical power of the study To detect the change in impulsivity and empathy resulted from the iTBS intervention, G*Power 3.1.9.2 was used to estimate sample size required in consideration of interaction effect (impulsivity group × iTBS conditions) of repeated measure ANOVA. The following parameters were selected: effect size f = 0.20 (equivalent to d = 0.40, estimated from the results of previous meta-analyses), alpha error probability = .05, power = (1- β error probability) = .80, number of groups = 2, number of measurements = 2 and correlation among repeated measurements = 0.6. A minimum of total sample size of 42 subjects will be required. Considering the dropout rate of 0.20 (according to previous rTMS studies), 54 subjects will be required for the study, including 27 high impulsivity participants and 27 low impulsivity participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsive Behavior, Empathy
Keywords
transcranial magnetic stimulation, theta burst stimulation, impulsivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
crossover (real and sham stimulation) design with randomised allocation of outcome examination
Masking
Participant
Masking Description
using a shall coil to mimic the active stimulation
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high impulsivity
Arm Type
Active Comparator
Arm Description
participants with high impulsivity (BIS >62), receiving active and sham repetitive transcranial magnetic stimulation [intermittent theta burst stimulation (iTBS)] in a randomised order
Arm Title
low impulsivity
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation
Other Intervention Name(s)
intermittent theta burst stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Impulsivity (performance-based)
Description
P(correct) from IST and K value from AAT
Time Frame
(usually 20 mins apart) the time just before rTMS and right after rTMS (usually 20 mins apart)
Title
empathy (performance-based)
Description
correct scores from RMET
Time Frame
baseline and right after rTMS (usually 20 mins apart)
Secondary Outcome Measure Information:
Title
Correlation between self-reported and performance-based impulsivity
Description
correlation coefficient between [P(correct)], K value and AUC and UPPS-P and BIS-11
Time Frame
baseline
Title
Correlation between self-reported and performance-based empathy
Description
correlation coefficient between RMET correct score and QCAE
Time Frame
baseline
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
The frequency of adverse events from each participant
Time Frame
through study completion, an average within 1 week

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males predominantly have higher impulsivity level compared to females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Völlm, PhD
Organizational Affiliation
Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2TU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of rTMS on Impulsivity and Empathy

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