NCT02119637

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

April 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
Last Updated

March 25, 2021

Status Verified

October 17, 2017

Enrollment Period

3.5 years

First QC Date

April 17, 2014

Last Update Submit

March 24, 2021

Conditions

Healthy Volunteer

Keywords

EmotionTactile DiscriminationTranscranial Magnetic Stimulation (TMS)SomatosensorySomatosensory Cortex

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Study Arms (2)

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.

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.

Device: Transcranial magnetic stimulation (TMS)Device: MRI

Interventions

Transcranial magnetic stimulation (TMS)DEVICE

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

Study 1 TMS to S1Study 2 TMS targeting S2/insula
MRIDEVICE

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

Study 1 TMS to S1Study 2 TMS targeting S2/insula

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between 18 and 45 years old
  • right-handed.
  • Fluent in English.
  • able to provide written informed consent.
  • 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).
  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • 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.

    PMID: 11439754BACKGROUND

  • 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.

    PMID: 21094177BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Mary C Bushnell, Ph.D.

    National Center for Complementary and Integrative Health (NCCIH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 21, 2014

Study Start

April 17, 2014

Primary Completion

October 17, 2017

Study Completion

October 17, 2017

Last Updated

March 25, 2021

Record last verified: 2017-10-17

Locations

US(1)