NCT03705936

Brief Summary

The purpose of the study is to determine the effects of giving 2 doses of brain stimulation through repetitive transcranial magnetic stimulation (rTMS) on swallowing neurophysiology (brain function) in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

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

October 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

October 24, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

October 10, 2018

Last Update Submit

November 3, 2020

Conditions

DeglutitionPhysiology

Keywords

Non-invasive brain stimulationSwallowingMetaplasticity

Outcome Measures

Primary Outcomes (2)

  • Pharyngeal motor evoked potentials (PMEPs)

    Motor evoked potentials from the pharynx will be elicited by single pulse transcranial magnetic stimulation and recorded.

    Change from baseline up to 150 minutes after rTMS

  • Thenar (hand) motor evoked potentials (TMEPs)

    Motor evoked potentials from the hand will be elicited by single pulse transcranial magnetic stimulation and recorded.

    Change from baseline up to 150 minutes after rTMS

Study Arms (8)

Sham 1Hz rTMS--5Hz rTMS

SHAM COMPARATOR

Participants will receive sham 1Hz rTMS, then immediately followed by 5Hz rTMS.

Device: rTMS

1Hz rTMS--5Hz rTMS

EXPERIMENTAL

Participants will receive 1Hz rTMS, then immediately followed by 5Hz rTMS.

Device: rTMS

1Hz rTMS--30-minute break--5Hz rTMS

EXPERIMENTAL

Participants will receive 1Hz rTMS, then followed by 30 minutes break, then followed by 5Hz rTMS.

Device: rTMS

1Hz rTMS--60-minute break--5Hz rTMS

EXPERIMENTAL

Participants will receive 1Hz rTMS, then followed by 60 minutes break, then followed by 5Hz rTMS.

Device: rTMS

Sham 5Hz rTMS--1Hz rTMS

SHAM COMPARATOR

Participants will receive sham 5Hz rTMS, then immediately followed by 1Hz rTMS.

Device: rTMS

5Hz rTMS--1Hz rTMS

EXPERIMENTAL

Participants will receive 5Hz rTMS, then immediately followed by 1Hz rTMS.

Device: rTMS

5Hz rTMS--45-minute break--1Hz rTMS

EXPERIMENTAL

Participants will receive 5Hz rTMS, then followed by 45 minutes break, then followed by 1Hz rTMS.

Device: rTMS

5Hz rTMS--90-minute break--1Hz rTMS

EXPERIMENTAL

Participants will receive 5Hz rTMS, then followed by 90 minutes break, then followed by 1Hz rTMS.

Device: rTMS

Interventions

rTMSDEVICE

rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.

1Hz rTMS--30-minute break--5Hz rTMS1Hz rTMS--5Hz rTMS1Hz rTMS--60-minute break--5Hz rTMS5Hz rTMS--1Hz rTMS5Hz rTMS--45-minute break--1Hz rTMS5Hz rTMS--90-minute break--1Hz rTMSSham 1Hz rTMS--5Hz rTMSSham 5Hz rTMS--1Hz rTMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers aged 18 years old or above; and
  • No medical complications or significant past medical history

You may not qualify if:

  • History of epilepsy;
  • Previous history of neurosurgery;
  • Previous swallowing problem;
  • Implanted brain electrodes, cardiac pacemaker; or
  • Use of medications (predominantly taking multiple anti-depressants) that lower neural threshold

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salford Royal Foundation Trust

Salford, Greater Manchester, M6 8Hd, United Kingdom

Location

Study Officials

  • Shaheen Hamdy, PhD, FRCP

    The University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurogastroenterology

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 15, 2018

Study Start

October 24, 2018

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)