NCT04209309

Brief Summary

Hyper- and hyposexuality occur frequently in a variety of psychiatric disorders and are difficult to treat. While there is meta-analytic evidence for the significant effect of non-invasive brain stimulation on drug and food craving, no study has investigated the potential of this technique to modulate sexual behavior. The efficacy of a single session of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the left or right dorsolateral prefrontal cortex (DLPFC) to reduce sexual arousal was tested against a sham stimulation. To test this hypothesis, we employed a randomized, double-blind, sham-controlled crossover study design. Nineteen healthy male participants received high-frequency rTMS over the left DLPFC, high-frequency rTMS over the right DLPFC and sham rTMS (each 10 Hz; 110% resting motor threshold; 60 trains with 50 pulses) in randomized and counterbalanced order with a one-week interval between stimulation sessions to avoid carryover effects. Participants were exposed to neutral and sexual cues before and after each intervention and rated their sexual arousal after each block of cue presentation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

1.8 years

First QC Date

December 17, 2019

Last Update Submit

December 19, 2019

Conditions

Keywords

sexual arousal

Outcome Measures

Primary Outcomes (1)

  • Change of sexual arousal

    short 10-item version of the Affect and Arousal Scale, which captures perceived genital, autonomic and psychological sexual arousal as well as state sexual desire

    immediately before and after the single session of rTMS

Study Arms (3)

leDLPFC

EXPERIMENTAL

single session rTMS of the left dorsolateral prefrontal cortex for 15 min (60 trains with 50 stimuli; 10 sec intertrain interval; 10 Hz; 110% RMT; 3000 pulses; coil positioning over the 10-20 EEG coordinate position F3)

Device: repetitive transcranial magnetic stimulation

riDLPFC

EXPERIMENTAL

single session rTMS of the right dorsolateral prefrontal cortex for 15 min (60 trains with 50 stimuli; 10 sec intertrain interval; 10 Hz; 110% RMT; 3000 pulses; coil positioning over the 10-20 EEG coordinate position F4)

Device: repetitive transcranial magnetic stimulation

shamDLPFC

SHAM COMPARATOR

single session sham rTMS over the medial prefrontal cortex for 15 min (60 trains with 50 stimuli; 10 sec intertrain interval; 10 Hz; 110% RMT; 3000 pulses; coil positioning over the midline with tilted coil)

Device: repetitive transcranial magnetic stimulation

Interventions

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • motor threshold below 55%
  • informed consent
  • male
  • years
  • heterosexual
  • right handedness

You may not qualify if:

  • contraindication for TMS
  • somatic or mental illnesses
  • intake of psychoactive drugs
  • left handedness
  • homo- or bisexual
  • paraphilia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 24, 2019

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 24, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Not allowed based on ethics vote.