RecruitingPHASE2, PHASE3INTERVENTIONAL

Bilateral Essential Tremor Treatment With Gamma Knife

This study is investigating a treatment called Gamma Knife for people with Essential Tremor, a condition that causes uncontrollable shaking. Specifically, it's for individuals who have already had successful Gamma Knife treatment on one side of their brain to help with their tremors, and are now considering having the treatment on the other side. Researchers want to see how safe and effective this second treatment is. They will carefully check for any side effects and see how much it improves people's tremors and overall quality of life. This is a combined Phase II and III study, meaning it's moving from an early safety check to a larger study looking at benefits.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Université de Sherbrooke

Enrolment target

Start

08 Jun 2021

Estimated completion

01 Oct 2026

Essential Tremor

What is this study about?

This study is all about helping people with Essential Tremor, a common condition that causes involuntary shaking, often in the hands, head or voice. The study is particularly looking at a treatment called Gamma Knife. This isn't surgery in the traditional sense, but a very focused type of radiation therapy that targets a tiny area in the brain to help manage tremors. It's a bit like using a magnifying glass to focus sunlight.

The main idea behind this study is to see how well and how safely a second Gamma Knife treatment works. It's for people who have already had good results from a Gamma Knife treatment on one side of their brain to help with their tremors, and are now considering having the treatment on the other side because that tremor is also affecting their daily life. The study aims to understand if treating both sides is a good option.

Researchers will be carefully watching for any side effects and measuring how much the treatment improves tremors and the overall quality of life for participants. This information will help doctors understand more about how to best use Gamma Knife for people with Essential Tremor in the future, potentially offering a new option for those who need treatment on both sides of their body.

Key takeaways

This study evaluates a second Gamma Knife treatment for Essential Tremor.
It's for people who've previously had one successful Gamma Knife treatment.
Researchers will check for safety and how much it improves tremors and daily life.
Participation involves one treatment session and follow-up for 3 years.
Eligible individuals must be 18+ with a clear Essential Tremor diagnosis.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a clear diagnosis of Essential Tremor from a specialist doctor. A key requirement is that you've already had a successful Gamma Knife treatment for your tremor on one side of your body more than a year ago.

Also, the tremor on the side that hasn't been treated yet must be significantly affecting your daily life, and you must be interested in getting treatment for that side. The study is looking for people who are physically able to come to follow-up appointments.

However, you wouldn't be able to join if you have significant problems with walking or balance, like needing a walking aid or falling often. Similarly, if you have severe speech problems that make it hard to understand you, this study might not be suitable. It’s also important that you can commit to all the follow-up visits.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Essential Tremor from a specialist?
Have you already had successful Gamma Knife treatment on one side of your body for tremor more than a year ago?
Does the tremor on your untreated side significantly impact your daily life?
Do you have good balance and speech?
Can you commit to attending follow-up appointments for 3 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a medical assessment to ensure you are suitable. If you are, you will then receive the Gamma Knife treatment for your tremor on the untreated side. This treatment is generally a single session.

After the treatment, you will have several follow-up visits with the study team. These visits will happen at 3, 6, 12, 24, and 36 months (3 years) after your treatment. During these visits, the team will check for any side effects, ask you about your tremors and how they are affecting your daily life (this might involve filling out questionnaires), and do some assessments. These may include filming your movements to objectively check your tremor, walking, and speech. There are no medications involved in the study; it's focused on the Gamma Knife procedure itself. The total duration of your participation, including follow-up, will be 3 years.

Potential risks and benefits

Participating in this study might offer the potential benefit of improving the tremor on the untreated side of your body, which could significantly enhance your daily activities and overall quality of life. However, as with any medical procedure, there are potential risks, including side effects from the Gamma Knife treatment. These will be carefully monitored throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

Toronto Western Hospital, University Health Network
Verified postcode
Toronto, Canada· Recruiting
CIUSSS de l'Estrie-CHUS - Hôpital Fleurimont
Verified postcode
Sherbrooke, Canada· Recruiting

Common questions

What is Essential Tremor?

Essential Tremor is a condition that causes uncontrollable shaking, most commonly in the hands, but it can also affect the head, voice, and other body parts.

What is Gamma Knife treatment?

Gamma Knife is a non-surgical treatment that uses highly focused radiation beams to target a very small area in the brain to help control tremors.

Is this a new treatment?

No, Gamma Knife has been used before for Essential Tremor, but this study specifically looks at treating the 'other' side for those who've already had it once.

How long will I be in the study?

If you join, your involvement will last for 3 years, including the treatment and regular follow-up appointments.

Can I stop participating at any time?

Yes, your participation is voluntary, and you can choose to leave the study at any point without it affecting your medical care.

How to find out more

Christian Iorio-Morin

christian.iorio-morin@usherbrooke.ca 819-346-1110 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.