Effects of rTMS on Impulsivity and Empathy

NCT03200873 | Completed DMC

• 1 other identifier: C200317
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Impulsive Behavior; Empathy

Keywords

transcranial magnetic stimulation; theta burst stimulation; impulsivity

Outcome Measures

Primary Outcomes (2)

• Impulsivity (performance-based)

  P(correct) from IST and K value from AAT

  (usually 20 mins apart) the time just before rTMS and right after rTMS (usually 20 mins apart)

• empathy (performance-based)

  correct scores from RMET

  baseline and right after rTMS (usually 20 mins apart)

Secondary Outcomes (2)

• Correlation between self-reported and performance-based impulsivity

  baseline

• Correlation between self-reported and performance-based empathy

  baseline

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  through study completion, an average within 1 week

Study Arms (2)

high impulsivity

ACTIVE COMPARATOR

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

low impulsivity

ACTIVE COMPARATOR

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

Interventions

repetitive transcranial magnetic stimulation DEVICE

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.

Also known as: intermittent theta burst stimulation

high impulsivity; low impulsivity

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Males predominantly have higher impulsivity level compared to females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

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

Nottingham, Nottinghamshire, NG7 2TU, United Kingdom

Location

MeSH Terms

Conditions

Impulsive Behavior

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Birgit Völlm, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: using a shall coil to mimic the active stimulation
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: crossover (real and sham stimulation) design with randomised allocation of outcome examination

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 27, 2017
• Study Start: May 17, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: May 2, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)