Essential TremorNCT05157321
Repetitive Transcranial Magnetic Stimulation in Essential Tremors Patients
A study testing Repetitive Transcranial Magnetic Stimulation in people with Essential Tremor, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of the study is to investigate the Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with Essential tremors or Essential tremors plus based on the movement disorders consensus criteria(appendix 1)
- Patient should have significant residual tremors despite of using appropriate medical treatment.
- Age: patient should be above 18 years old.
- Gender: males and females.
Who cannot join
- Patients with history of seizures.
- Patient receiving tremor active drugs including:
- Central cholinergic drugs (acetylcholine chloride, muscarinic and nicotinic agonists, anticholinesterases, and aminopropranolols)
- Central monoaminergic drugs (neuroleptics, phenylethylamines, and indoles)
- Peripheral adrenergic drugs (lithium carbonate, amphetamine sulfate, adrenocorticosteroids, and thyroid hormone supplements)
- Anticonvulsants (valproic acid), bronchodilators (theophylline and terbutaline sulfate)
Show all 18Show fewer
- Antidepressants (amitriptyline hydrochloride).
- patients who have metal or electronic device implanted in their body such as :
- cardiac peace maker
- Aneurysm clips or coils
- Stents in the neck or brain
- Deep brain stimulators
- Spinal cord stimulators
- Electrodes to monitor brain activity
- Metallic implants in ears and eyes
- Bullet fragments in or near the head
- Baclofen pumps
- Other metal devices or object implanted in or near the head
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors
The aim of the study is to investigate the Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors.
Read the detailed description
Prior to start of rTMS sessions, Clinical evaluation and scaling of tremors using the ET rating scale (Fahn, Tolosa, Marin Tremor Rating Scale) will be employed on the participants in both groups.
rTMS frequency of 1Hz will be delivered to each of the participants in both groups. Each session will be administered once daily for 3 days a week for 4 weeks. 1200 pulses (30 pulses per train with total 40 trains having inter-train delay of 3 seconds) per session will be provided with the coil placed on both cerebellar hemispheres. rTMS frequency of 1Hz was kept constant based on previous studies.
rTMS sessions will be administered by trained professionals who was kept blinded to the research protocols used in the study. After completion of therapeutic programs (after 4 weeks), the participants will be asked to undergo post assessment of Fahn, Tolosa, Marin Tremor Rating Scale at the end of last rTMS session, 1 month, 3 months later.
- Conditions
- Essential Tremor
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation
- Keywords
- rTMS, essential tremors
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
TMS device will deliver repetitive trains of magnetic pulses using Magstim Rapid 2 with angulated figure of eight shaped coil. The device comprised two-channel Neuro-EMG-MS digital system for determining the motor threshold of the patients that will be used for establishing the threshold intensity for stimulation. The figure of eight-shaped coil generated a magnetic field of up to 4 Tesla that penetrates the cranium, enters into the soft tissue of the brain and henceforth stimulates the motor neurons.
Sham Repetitive Transcranial Magnetic StimulationDevice
Sham Repetitive Transcranial Magnetic Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | The patients in this group will receive active repetitive transcranial magnetic stimulation sessions for 4 weeks. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| control group | Sham comparator | The patients in this group will receive sham repetitive transcranial magnetic stimulation sessions for 4 weeks. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in severity of essential tremors
Fahn, Tolosa, Marin Tremor Rating Scale
Measured: 1 day, 1 month, and 3 months following the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start10 Dec 2021
- Primary completion15 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Fathy Mohammed Mohammed, Al-Azhar University
- Investigators
- Mohamed Al-Bahay M. Reda, professor, Study chair, Faculty of Medicine, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157321
- Sponsor's protocol ID
- 0000039
- Status last verified
- May 2022
- First submitted
- 8 Dec 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors
- ClinicalTrials.gov ID
- NCT05157321
- Acronym / sponsor ID
- 0000039
- Conditions
- Essential Tremor
- Keywords
- rTMS, essential tremors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors.
Detailed description
Prior to start of rTMS sessions, Clinical evaluation and scaling of tremors using the ET rating scale (Fahn, Tolosa, Marin Tremor Rating Scale) will be employed on the participants in both groups.
rTMS frequency of 1Hz will be delivered to each of the participants in both groups. Each session will be administered once daily for 3 days a week for 4 weeks. 1200 pulses (30 pulses per train with total 40 trains having inter-train delay of 3 seconds) per session will be provided with the coil placed on both cerebellar hemispheres. rTMS frequency of 1Hz was kept constant based on previous studies.
rTMS sessions will be administered by trained professionals who was kept blinded to the research protocols used in the study. After completion of therapeutic programs (after 4 weeks), the participants will be asked to undergo post assessment of Fahn, Tolosa, Marin Tremor Rating Scale at the end of last rTMS session, 1 month, 3 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Device: Repetitive Transcranial Magnetic StimulationThe patients in this group will receive active repetitive transcranial magnetic stimulation sessions for 4 weeks. |
| control group | Sham comparator | Device: Sham Repetitive Transcranial Magnetic StimulationThe patients in this group will receive sham repetitive transcranial magnetic stimulation sessions for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient diagnosed with Essential tremors or Essential tremors plus based on the movement disorders consensus criteria(appendix 1)
- Patient should have significant residual tremors despite of using appropriate medical treatment.
- Age: patient should be above 18 years old.
- Gender: males and females.
Key exclusion criteria (18 listed)
- Patients with history of seizures.
- Patient receiving tremor active drugs including:
- patients who have metal or electronic device implanted in their body such as :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationTMS device will deliver repetitive trains of magnetic pulses using Magstim Rapid 2 with angulated figure of eight shaped coil. The device comprised two-channel Neuro-EMG-MS digital system for determining the motor threshold of the patients that will be used for establishing the threshold intensity for stimulation. The figure of eight-shaped coil generated a magnetic field of up to 4 Tesla that penetrates the cranium, enters into the soft tissue of the brain and henceforth stimulates the motor neurons. | Device | Study Group |
| Sham Repetitive Transcranial Magnetic StimulationSham Repetitive Transcranial Magnetic Stimulation | Device | control group |
Primary outcome
change in severity of essential tremors
Time frame: 1 day, 1 month, and 3 months following the end of treatment.
Fahn, Tolosa, Marin Tremor Rating Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Al-Bahay M. Reda, professor study chair
Faculty of Medicine, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Essential Tremor, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in severity of essential tremors (time frame: 1 day, 1 month, and 3 months following the end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.