The Effects of Cerebellar rTMS on Brain Activity

NCT05736380 | Suspended

• 1 other identifier: IRAS 256390
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Swallowing function is controlled by two swallowing centres (one on each half of the brain). There is a dominant and non-dominant swallowing centre. Damage to any part of the brain can lead to swallowing problems, for example in strokes. Recovery of the ability to swallow is associated with increased activity (compensation) over the undamaged centre. The cerebellum is an area of the brain involved in the control and modulation of muscle movements. It is found at the back of the skull. Anatomical evidence exists, showing cerebellar outputs projecting to several cortical areas, including the primary motor cortex (M1). Moreover, brain imaging studies have shown activation of the cerebellum during swallowing using positron emission tomography (PET) and magnetic resonance imaging (MRI). Over the past few years studies have tried to improve swallowing function using techniques to stimulate regions of the brain and encourage compensation. Repetitive transcranial magnetic stimulation (rTMS) is a technique which can temporarily increase or suppress activity over regions of the brain. No imaging studies have been conducted which have looked at how the brain is affected by cerebellar rTMS. The investigators hypothesise that cerebellar rTMS will cause increased activity in swallowing associated areas in the brain, including the cortex and brainstem

Conditions

The Effects of Cerebellar rTMS on the Brain

Outcome Measures

Primary Outcomes (1)

• Differential blood flood (fMRI)

  Differential blood flow in brain regions post cerebellar rTMS (compared to sham)

  15 minutes post cerebellar rTMS

Study Arms (2)

Unilateral cerebellar rTMS

ACTIVE COMPARATOR

Device: Cerebellar rTMS

Sham cerebellar rTMS

SHAM COMPARATOR

Device: Sham cerebellar rTMS

Interventions

Cerebellar rTMS DEVICE

250 pulses at 10 Hertz over the cerebellum

Unilateral cerebellar rTMS

Sham cerebellar rTMS DEVICE

Sham cerebellar rTMS

Sham cerebellar rTMS

Eligibility Criteria

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

You may qualify if:

• Healthy adults above 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Upper G.I laboratory, Salford Royal Hospital

Manchester, Greater Manchester, M6 8HD, United Kingdom

Location

Study Officials

• Shaheen Hamdy

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Over the course of two visits to the laboratory, each participant will be randomised to either real or sham cerebellar rTMS. Each participant will undergo both procedures.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Over the course of two visits to the laboratory, each participant will undergo either real or sham cerebellar rTMS. Afterwards they will have functional magnetic resonance imaging of their brains.

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: February 21, 2023
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)