Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal

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: NCT04209309
Recruitment Status : Completed
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg

Tracking Information
First Submitted Date  ICMJE December 17, 2019
First Posted Date  ICMJE December 24, 2019
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE October 1, 2014
Actual Primary Completion Date July 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2019)
Change of sexual arousal [ Time Frame: immediately before and after the single session of rTMS ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal
Official Title  ICMJE Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Transcranial Magnetic Stimulation
Intervention  ICMJE Device: repetitive transcranial magnetic stimulation
Study Arms  ICMJE
  • Experimental: leDLPFC
    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)
    Intervention: Device: repetitive transcranial magnetic stimulation
  • Experimental: riDLPFC
    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)
    Intervention: Device: repetitive transcranial magnetic stimulation
  • Sham Comparator: shamDLPFC
    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)
    Intervention: Device: repetitive transcranial magnetic stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2019)
19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2016
Actual Primary Completion Date July 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • motor threshold below 55%
  • informed consent
  • male
  • 18-50 years
  • heterosexual
  • right handedness

Exclusion Criteria:

  • contraindication for TMS
  • somatic or mental illnesses
  • intake of psychoactive drugs
  • left handedness
  • homo- or bisexual
  • paraphilia
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04209309
Other Study ID Numbers  ICMJE 13-101-0117
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Not allowed based on ethics vote.
Responsible Party Berthold Langguth, MD, Ph.D., University of Regensburg
Study Sponsor  ICMJE University of Regensburg
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Regensburg
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP