Aftereffects of PES Preconditioned with RTMS on the Human Pharyngeal Motor Cortex

NCT06884488 | Recruiting

• 1 other identifier: 2024-20990-37010
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to optimize the excitatory brain effects of combined neuromodulatory therapies on swallowing areas of the brain. The main question it aims to answer is: Does preconditioning with 1 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) delivered over hemispheric pharyngeal areas enhance the activating effects of pharyngeal electrical stimulation (PES) on cortical excitability? Participants will:

• Visit the department three times, with at least a one-week gap between visits.
• Undergo baseline measurements for Pharyngeal motor evoked potential (PMEP) and Thenar motor evoked potential (TMEP), involving an electromyography (EMG) pharyngeal catheter inserted into the pharynx and gel electrodes to detect muscle activity.
• Be randomly allocated to one of the three preconditioning-conditioning procedures during each visit : 1Hz rTMS followed by 5Hz PES, sham 1Hz rTMS followed by 5Hz PES, and 1Hz rTMS followed by sham 5Hz PES
• Real rTMS will involve a figure-of-eight coil flat against the head delivering 1Hz stimulation at 90% of the thenar resting motor threshold.
• Sham rTMS will involve holding the coil perpendicular to the scalp to prevent brain stimulation.
• PES will involve a catheter delivering 0.2-ms pulses at 5Hz and 75% of the maximal tolerated intensity for 10 minutes. Sham PES will involve deactivating the current generator.
• Complete PMEP and TMEP measurements at baseline before intervention and every 15 minutes from 0 - 60 minutes after the rTMS-PES procedure.
• Complete a survey regarding tolerability and safety at the end of each visit.

Conditions

Healthy Subjects (HS)

Outcome Measures

Primary Outcomes (2)

• Percentage change of the amplitude of PMEP after intervention

  The percentage change (in percents) of the amplitude (in millivolts) of bilateral PMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.

  Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention

• Percentage change of the latency of PMEP after intervention

  The percentage change (in percents) of the latency (in milliseconds) of bilateral PMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.

  Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention

Secondary Outcomes (2)

• Percentage change of the amplitude of TMEP after intervention

  Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention

• Percentage change of the latency of TMEP after intervention

  Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention

Study Arms (3)

real rTMS + real PES

EXPERIMENTAL

Participants will receive real 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive real 5Hz PES.

Device: repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK); Device: pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)

sham rTMS + real PES

SHAM COMPARATOR

Participants will receive sham 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive real 5Hz PES.

Device: pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK); Device: sham repetitive transcranial magnetic stimulation(Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK)

real rTMS + sham PES

SHAM COMPARATOR

Participants will receive real 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive sham 5Hz PES.

Device: repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK); Device: sham pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK)

Interventions

repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK) DEVICE

The paradigm will be applied over the dominant cerebral hemisphere for 10 minutes (600 pulses) over the dominant pharyngeal motor cortex capped at 120% of pharyngeal resting motor threshold.

real rTMS + real PES; real rTMS + sham PES

pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK) DEVICE

The PES (0.2-ms pulses, 280 V) was delivered at a set frequency (5 Hz), intensity (75% of maximal tolerated), and duration (10 minutes), which have been reported as the most effective parameters for PES.

real rTMS + real PES; sham rTMS + real PES

sham repetitive transcranial magnetic stimulation(Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK) DEVICE

Sham rTMS is delivered with the coil tilted to its side at 90 degrees and with the identical stimulation conditions as active 1 Hz rTMS.

sham rTMS + real PES

sham pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK) DEVICE

For sham pharyngeal stimulation, the same method including the insertion of the catherter will be employed without actual electrical stimulation.

real rTMS + sham PES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers over the age of 18 will be recruited through adverts placed around Salford Royal Hospital, on a University of Manchester website which advertises for research volunteers and through a departmental database of volunteers who have expressed an interest in future research. There is no upper age limit for potential participants.

You may not qualify if:

• The presence or a history of:
• Epilepsy
• Cardiac pacemaker
• Previous brain surgery
• Previous swallowing problems
• The use of medication which acts on the central nervous system
• Any implanted metal in the head
• Pregnancy (self-declared)

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

University of Manchester

Manchester, M6 8JH, United Kingdom

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Shaheen Hamdy, PhD

  The University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng Dai, PhD

CONTACT

44 7585922413; meng.dai@manchester.ac.uk

Ayodele Sasegbon, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 19, 2025
• Study Start: September 14, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 19, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)