Healthy VolunteerNCT02119637
Effects of Transcranial Magnetic Stimulation (TMS) on Somatosensory Perception
An observational study of Healthy Volunteer, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
Background: Different parts of the brain are involved in feeling touch. Researchers want to study whether repetitive magnetic stimulation (rTMS) to the sensory cortex affects how sensation feels. rTMS is a repeated magnetic pulse that interferes with brain activity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Transcranial magnetic stimulation (TMS) and MRI
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2014to 17 Oct 2017
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between 18 and 45 years old
- right-handed.
- Fluent in English.
- able to provide written informed consent.
Who cannot join
- Has a dermatological condition such as scars, burns, callouses, or tattoos that might influence cutaneous sensibility on the hands
- Has had recent or permanent injury of upper limbs or amputation or use of prosthetic arm or leg
- Used recreational drugs within the past month
- Is pregnant or breastfeeding.
- Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months).
- Has a major medical condition, such as kidney, liver, cardiovascular, autonomic, pulmonary, or neurological problems (including blindness or deafness) or a chronic systemic disease (e.g. diabetes).
Show all 20Show fewer
- Has a medical condition potentially affecting somatosensation (e.g. Raynaud s Disease, peripheral neuropathy, or circulatory disorder).
- Participant has or had psychiatric disorders such as major depression, major anxiety-related problems, substance or alcohol dependence or abuse, post-traumatic stress syndrome, bipolar disorder, psychosis, or suicide attempts or persistent suicide ideation.
- Has metal implants or fragments in the body as this would make having an MRI scan unsafe. This includes pacemakers, medication pumps, aneurysm clips, metallic prostheses (such as metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have.
- Is uncomfortable in closed spaces (has claustrophobia) so that he/she would feel uncomfortable in the MRI machine, or a condition that prevents him/her from lying flat for up to 1 hour or rotating palm up for 15 minutes while lying flat.
- Weight of 275 pounds or higher.
- History of head trauma that was diagnosed as a concussion or was associated with loss of consciousness or was associated with loss of consciousness.
- Personal history of a seizure or first degree relative with a seizure disorder
- Participation in brain stimulation within one week of any TMS session in this study
- Use of neuro-active drugs including opioids, antidepressants, anticonvulsants/antiepileptics, antipsychotics, dopamine agonists, sleep or anxiety medications, stimulants like methylphenidate (Ritalin), antihistamines, certain viral medications, or any other medication affecting the central nervous system
- History of hearing loss
- Obtained less than 6 hours of sleep the night before either TMS session (will be asked at each TMS session)
- Consumed more than 16oz of coffee or an energy drink (anything with 500mg caffeine or more) on the day of the TMS session. (Caffeine > 500mg and sleep deprivation can increase seizure risk (Engel J, 2008).
- Consumed alcohol on the day of the TMS session or shows signs of alcohol intoxication or alcohol withdrawal syndrome
- Motor threshold over 82% of Magstim output.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Different parts of the brain are involved in feeling touch. Researchers want to study whether repetitive magnetic stimulation (rTMS) to the sensory cortex affects how sensation feels. rTMS is a repeated magnetic pulse that interferes with brain activity. It affects a small part of the brain beneath the scalp. Researchers want to find out the role of sensory cortex in sensing different types of touch.
Read more
Objectives:
- To find out the role of sensory cortex, a brain area, in sensing different types of touch.
Eligibility:
- Healthy adults ages 18 45.
Design:
- Participants will be pre-screened with a telephone interview. Then they will be screened with physical and psychological exams and a urine test.
- In Session 1, participants will have an MRI brain scan and fill out questionnaires.
- For MRI, a magnetic field and radio waves take pictures of the brain. Participants will lie on a table that slides in and out of a metal cylinder. A coil will be placed over their head. They will perform a task during the scan. The scanner makes loud knocking noises. Participants will get earplugs. They will be in the scanner for up to 60 minutes.
- In Sessions 2 and 3, participants will take urine tests. Their perception of touch will be measured. Then rTMS will be used to stimulate their sensory cortex and scalp for about 20 minutes. Their perception of touch will be measured again.
- For rTMS, a wire coil is held on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse that affects activity in the brain.
Read the detailed description
This study will test how parts of sensory cortex relate to different aspects of touch sensation. Healthy male and female adults (ages 18-45) will be enrolled. We will use low frequency repetitive transcutaneous magnetic stimulation (rTMS) to temporarily reduce activation in parts of the sensory cortex and will examine the effect of this procedure on perception of touch stimuli. After screening, participants will undergo three testing sessions. Session 1 will involve questionnaires and anatomical and functional MRI scans (non-invasive brain imaging) that will be used for localizing the correct regions to stimulate with the rTMS. Sessions 2 and 3 will involve active and control rTMS and testing of gentle (non-painful) touch sensation.
- Conditions
- Healthy Volunteer
- Being tested
- Transcranial magnetic stimulation (TMS), MRI
- Keywords
- Emotion, Tactile Discrimination, Transcranial Magnetic Stimulation (TMS), Somatosensory, Somatosensory Cortex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation (TMS)Device
1 Hz rTMS for 20 minutes. TMS sessions were separated by at least 24 hours.
MRIDevice
Anatomical MRI, resting state MRI and functional MRI using gentle brushing and finger movement
| Study group | Role | What they receive |
|---|---|---|
| Study 1 TMS to S1 | Cohort of healthy participants received screening, brain MRI, TMS to S1 and vertex, and somatosensory testing, including 2-point discrimination and gentle brushing. Receives: Device: Transcranial magnetic stimulation (TMS); Device: MRI | |
| Study 2 TMS targeting S2/insula | Cohort of healthy participants received screening, brain MRI before and after TMS, TMS to S2/insula and vertex, and somatosensory testing, including 2-point discrimination and gentle brushing. Receives: Device: Transcranial magnetic stimulation (TMS); Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-point touch discrimination on hand during active and control rTMS sessions
Primary outcome for Study 1. Touched palm with one or two tips separated by 4 distances. Subject reported if he/she felt one or two touches at each separation distance.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study start17 Apr 2014
- Primary completion17 Oct 2017
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mary C Bushnell, Ph.D., Principal investigator, National Center for Complementary and Integrative Health (NCCIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119637
- Sponsor's protocol ID
- 140100
- Other IDs
- 14-AT-0100
- Status last verified
- 17 Oct 2017
- First submitted
- 17 Apr 2014
- Last updated
- 25 Mar 2021
- Results posted
- No
Publications
Baron-Cohen S, Wheelwright S, Skinner R, Martin J, Clubley E. The autism-spectrum quotient (AQ): evidence from Asperger syndrome/high-functioning autism, males and females, scientists and mathematicians. J Autism Dev Disord. 2001 Feb;31(1):5-17. doi: 10.1023/a:1005653411471.
PubMed 11439754Bolognini N, Rossetti A, Casati C, Mancini F, Vallar G. Neuromodulation of multisensory perception: a tDCS study of the sound-induced flash illusion. Neuropsychologia. 2011 Jan;49(2):231-7. doi: 10.1016/j.neuropsychologia.2010.11.015. Epub 2010 Nov 19.
PubMed 21094177
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Magnetic Stimulation (TMS) on Somatosensory Perception
- ClinicalTrials.gov ID
- NCT02119637
- Acronym / sponsor ID
- 140100
- Conditions
- Healthy Volunteer
- Keywords
- Emotion, Tactile Discrimination, Transcranial Magnetic Stimulation (TMS), Somatosensory, Somatosensory Cortex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- 17 Apr 2014
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 21 Apr 2014 (estimated)
- 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.
Background:
- Different parts of the brain are involved in feeling touch. Researchers want to study whether repetitive magnetic stimulation (rTMS) to the sensory cortex affects how sensation feels. rTMS is a repeated magnetic pulse that interferes with brain activity. It affects a small part of the brain beneath the scalp. Researchers want to find out the role of sensory cortex in sensing different types of touch.
Objectives:
- To find out the role of sensory cortex, a brain area, in sensing different types of touch.
Eligibility:
- Healthy adults ages 18 45.
Design:
- Participants will be pre-screened with a telephone interview. Then they will be screened with physical and psychological exams and a urine test.
- In Session 1, participants will have an MRI brain scan and fill out questionnaires.
- For MRI, a magnetic field and radio waves take pictures of the brain. Participants will lie on a table that slides in and out of a metal cylinder. A coil will be placed over their head. They will perform a task during the scan. The scanner makes loud knocking noises. Participants will get earplugs. They will be in the scanner for up to 60 minutes.
- In Sessions 2 and 3, participants will take urine tests. Their perception of touch will be measured. Then rTMS will be used to stimulate their sensory cortex and scalp for about 20 minutes. Their perception of touch will be measured again.
- For rTMS, a wire coil is held on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse that affects activity in the brain.
Detailed description
This study will test how parts of sensory cortex relate to different aspects of touch sensation. Healthy male and female adults (ages 18-45) will be enrolled. We will use low frequency repetitive transcutaneous magnetic stimulation (rTMS) to temporarily reduce activation in parts of the sensory cortex and will examine the effect of this procedure on perception of touch stimuli. After screening, participants will undergo three testing sessions. Session 1 will involve questionnaires and anatomical and functional MRI scans (non-invasive brain imaging) that will be used for localizing the correct regions to stimulate with the rTMS. Sessions 2 and 3 will involve active and control rTMS and testing of gentle (non-painful) touch sensation.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study 1 TMS to S1 | – | Device: Transcranial magnetic stimulation (TMS), Device: MRICohort of healthy participants received screening, brain MRI, TMS to S1 and vertex, and somatosensory testing, including 2-point discrimination and gentle brushing. |
| Study 2 TMS targeting S2/insula | – | Device: Transcranial magnetic stimulation (TMS), Device: MRICohort of healthy participants received screening, brain MRI before and after TMS, TMS to S2/insula and vertex, and somatosensory testing, including 2-point discrimination and gentle brushing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
Key exclusion criteria (20 listed)
- Has a dermatological condition such as scars, burns, callouses, or tattoos that might influence cutaneous sensibility on the hands
- Has had recent or permanent injury of upper limbs or amputation or use of prosthetic arm or leg
- Used recreational drugs within the past month
- Is pregnant or breastfeeding.
- Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months).
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 |
|---|---|---|
| Transcranial magnetic stimulation (TMS)1 Hz rTMS for 20 minutes. TMS sessions were separated by at least 24 hours. | Device | Study 1 TMS to S1, Study 2 TMS targeting S2/insula |
| MRIAnatomical MRI, resting state MRI and functional MRI using gentle brushing and finger movement | Device | Study 1 TMS to S1, Study 2 TMS targeting S2/insula |
Primary outcome
2-point touch discrimination on hand during active and control rTMS sessions
Time frame: 2 years
Primary outcome for Study 1. Touched palm with one or two tips separated by 4 distances. Subject reported if he/she felt one or two touches at each separation distance.
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 25 Mar 2021.
- Background: PubMed 11439754Baron-Cohen S, Wheelwright S, Skinner R, Martin J, Clubley E. The autism-spectrum quotient (AQ): evidence from Asperger syndrome/high-functioning autism, males and females, scientists and mathematicians. J Autism Dev Disord. 2001 Feb;31(1):5-17. doi: 10.1023/a:1005653411471.
- Background: PubMed 21094177Bolognini N, Rossetti A, Casati C, Mancini F, Vallar G. Neuromodulation of multisensory perception: a tDCS study of the sound-induced flash illusion. Neuropsychologia. 2011 Jan;49(2):231-7. doi: 10.1016/j.neuropsychologia.2010.11.015. Epub 2010 Nov 19.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Mary C Bushnell, Ph.D. principal investigator
National Center for Complementary and Integrative Health (NCCIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 4 inclusion and 20 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 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
2-point touch discrimination on hand during active and control rTMS sessions (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02119637, which also lists 2 linked publications.
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 25 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.