Transcranial Magnetic StimulationNCT04209309
Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal
A study testing repetitive transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation, run by University of Regensburg.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Transcranial Magnetic Stimulation
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2014to 1 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- motor threshold below 55%
- informed consent
- male
- 18-50 years
- heterosexual
- right handedness
Who cannot join
- contraindication for TMS
- somatic or mental illnesses
- intake of psychoactive drugs
- left handedness
- homo- or bisexual
- paraphilia
About this study
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.
- Conditions
- Transcranial Magnetic Stimulation
- Being tested
- repetitive transcranial magnetic stimulation
- Keywords
- sexual arousal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Device: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately before and after the single session of rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Oct 2014
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209309
- Sponsor's protocol ID
- 13-101-0117
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed based on ethics vote.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal
- ClinicalTrials.gov ID
- NCT04209309
- Acronym / sponsor ID
- 13-101-0117
- Conditions
- Transcranial Magnetic Stimulation
- Keywords
- sexual arousal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| leDLPFC | Experimental | Device: repetitive transcranial magnetic stimulationsingle 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) |
| riDLPFC | Experimental | Device: repetitive transcranial magnetic stimulationsingle 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) |
| shamDLPFC | Sham comparator | Device: repetitive transcranial magnetic stimulationsingle 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- motor threshold below 55%
- informed consent
- male
- 18-50 years
- heterosexual
Key exclusion criteria (6 listed)
- contraindication for TMS
- somatic or mental illnesses
- intake of psychoactive drugs
- left handedness
- homo- or bisexual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulation | Device | leDLPFC, riDLPFC, shamDLPFC |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Individual participant dataSharing planned: No. Not allowed based on ethics vote.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation, run by University of Regensburg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of sexual arousal (time frame: immediately before and after the single session of rTMS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.