Effects of Transcranial Magnetic Stimulation (TMS) on Somatosensory Perception

NCT ID: NCT02119637

Last Updated: 2021-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-17

Study Completion Date

2017-10-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Transcranial magnetic stimulation (TMS)

Intervention Type DEVICE

1 Hz rTMS for 20 minutes. TMS sessions were separated by at least 24 hours.

MRI

Intervention Type DEVICE

Anatomical MRI, resting state MRI and functional MRI using gentle brushing and finger movement

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.

Transcranial magnetic stimulation (TMS)

Intervention Type DEVICE

1 Hz rTMS for 20 minutes. TMS sessions were separated by at least 24 hours.

MRI

Intervention Type DEVICE

Anatomical MRI, resting state MRI and functional MRI using gentle brushing and finger movement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial magnetic stimulation (TMS)

1 Hz rTMS for 20 minutes. TMS sessions were separated by at least 24 hours.

Intervention Type DEVICE

MRI

Anatomical MRI, resting state MRI and functional MRI using gentle brushing and finger movement

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. between 18 and 45 years old
2. right-handed.
3. Fluent in English.
4. able to provide written informed consent.

EXCLUSION CRITEIRA:

1. Has a dermatological condition such as scars, burns, callouses, or tattoos that might influence cutaneous sensibility on the hands
2. Has had recent or permanent injury of upper limbs or amputation or use of prosthetic arm or leg
3. Used recreational drugs within the past month
4. Is pregnant or breastfeeding.
5. Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months).
6. 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).
7. Has a medical condition potentially affecting somatosensation (e.g. Raynaud s Disease, peripheral neuropathy, or circulatory disorder).
8. 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.
9. 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.
10. 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.
11. Weight of 275 pounds or higher.
12. History of head trauma that was diagnosed as a concussion or was associated with loss of consciousness or was associated with loss of consciousness.
13. Personal history of a seizure or first degree relative with a seizure disorder
14. Participation in brain stimulation within one week of any TMS session in this study
15. 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
16. History of hearing loss
17. Obtained less than 6 hours of sleep the night before either TMS session (will be asked at each TMS session)
18. 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).
19. Consumed alcohol on the day of the TMS session or shows signs of alcohol intoxication or alcohol withdrawal syndrome
20. Motor threshold over 82% of Magstim output.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mary C Bushnell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Center for Complementary and Integrative Health (NCCIH)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11439754 (View on PubMed)

Bolognini 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.

Reference Type BACKGROUND
PMID: 21094177 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14-AT-0100

Identifier Type: -

Identifier Source: secondary_id

140100

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Characterizing the Scalp Tolerability of TMS
NCT06354686 ACTIVE_NOT_RECRUITING NA
Modeling TMS-induced Cortical Network Activity
NCT05288959 NOT_YET_RECRUITING NA
Effect of TMS on PTSD Biomarkers
NCT04563078 COMPLETED NA