Essential TremorPhase 2FRACTHALNCT04727658
Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)
A Phase 2 study testing Radiosurgical thalamotomy on GammaKnife in people with Essential Tremor and Parkinsonian Disorders, run by Centre Hospitalier Universitaire de Nice at 1 site in Monaco.
Trial summary
Radiosurgical thalamotomy on GammaKnife has been shown to be effective in the management of tremors. However, several teams describe a significant risk of severe neurological complications. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Essential Tremor, Parkinsonian Disorders
- What is being tested?
- Radiosurgical thalamotomy on GammaKnife
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteMonaco
- Study dates
- 1 Jul 2021to 20 Jun 2024
- Phase
- Phase 2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with disabling essential tremor, dystonic and / or parkinsonian in one or more limbs superiors ;
- patient contraindicated or refusing deep brain stimulation ;
- patient ≥ 18 years old,
- women of childbearing potential must take effective contraception ;
- signature of informed consent ; p- atients who benefited from contralateral thalami c stimulation can be included in the study
Who cannot join
- brain irradiation history ;
- contraindication or inability to perform injected MRI ;
- life expectancy <12 months ;
- claustrophobic patient who cannot stand the radiotherapy mask ;
- abnormal anatomy of the thalamic region ;
- treatment with a trial drug within 30 days of entering the study ;
- presence of medical, psychological, social or geographic factors likely to modify the patient's compliance with the protocol under study or the monitoring or signing of the consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Linac FRACtionated Radiosurgical THALamotomy in Tremors : a Phase II Study
Radiosurgical thalamotomy on GammaKnife has been shown to be effective in the management of tremors. However, several teams describe a significant risk of severe neurological complications. In addition, fitting the invasive frame and the need to travel to GammKnife centers often limit access to treatment in this population of elderly patients.
Linear accelerators have greatly improved their precision, now reaching that of GammaKnife. A possible alternative is therefore to treat patients on linear accelerators, without an invasive frame.
Read more
The objective of the FRACTHAL study is to assess the feasibility and safety of treatment of essential and / or parkinsonian tremor by fractional radiosurgical thalamotomy on a linear accelerator.
The main hypothesis of the FRACTHAL study is based on the fact that dividing the dose into 3 sessions will both protect healthy tissue around the target while maintaining therapeutic efficacy on the treatment target.
- Conditions
- Essential Tremor, Parkinsonian Disorders
- Being tested
- Radiosurgical thalamotomy on GammaKnife
- Medical subject headings
- Essential Tremor, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiosurgical thalamotomy on GammaKnifeRadiation
fractional radiosurgical thalamotomy on an accelerator (3 sessions of 50 Gy at the isocenter )
| Study group | Role | What they receive |
|---|---|---|
| Radiosurgical thalamotomy on GammaKnife | Experimental | Not described Receives: Radiation: Radiosurgical thalamotomy on GammaKnife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment toxicity
The treatment will be considered toxic in the event of the appearance, within 12 months after treatment, of non-regressive toxicity of grade> 1 according to the NCI-CTCAE V5.0 scale (symptomatic neurological deficit interfering with daily activities), and that this deficit is related to the treatment.
Measured: 12 months
Secondary outcomes (2)
Treatment accuracy
Measurement of the shift between the position of the treatment isocenter and the position of the hypersignal center visible on the injected MRI
Measured: At 6 and 12 months
Tremor improvement
It will be measured by decrease in FTM scale score for contralateral upper limb
Measured: At 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Jul 2021
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Why it stopped: The treatment at hand was not efficient enough.
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 Centre Hospitalier Universitaire de NiceThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will be carried out according to a design by Simon in two stages (Simon, 1989). First step: 14 patients will be included in the study. When the 14th patient has been treated, the inclusions will be suspended for 1 year until analysis of the primary endpoint. • Second stage: 34 additional patients will be recruited for a total of 48 patients.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727658
- Sponsor's protocol ID
- 18-01
- Acronym
- FRACTHAL
- Status last verified
- May 2026
- First submitted
- 11 Jan 2021
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data sharing is planned
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linac FRACtionated Radiosurgical THALamotomy in Tremors : a Phase II Study
- ClinicalTrials.gov ID
- NCT04727658
- Acronym / sponsor ID
- FRACTHAL / 18-01
- Conditions
- Essential Tremor, Parkinsonian Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The treatment at hand was not efficient enough.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 27 Jan 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.
Radiosurgical thalamotomy on GammaKnife has been shown to be effective in the management of tremors. However, several teams describe a significant risk of severe neurological complications. In addition, fitting the invasive frame and the need to travel to GammKnife centers often limit access to treatment in this population of elderly patients.
Linear accelerators have greatly improved their precision, now reaching that of GammaKnife. A possible alternative is therefore to treat patients on linear accelerators, without an invasive frame.
The objective of the FRACTHAL study is to assess the feasibility and safety of treatment of essential and / or parkinsonian tremor by fractional radiosurgical thalamotomy on a linear accelerator.
The main hypothesis of the FRACTHAL study is based on the fact that dividing the dose into 3 sessions will both protect healthy tissue around the target while maintaining therapeutic efficacy on the treatment target.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be carried out according to a design by Simon in two stages (Simon, 1989). First step: 14 patients will be included in the study. When the 14th patient has been treated, the inclusions will be suspended for 1 year until analysis of the primary endpoint. • Second stage: 34 additional patients will be recruited for a total of 48 patients.
| Arm | Type | Receives |
|---|---|---|
| Radiosurgical thalamotomy on GammaKnife | Experimental | Radiation: Radiosurgical thalamotomy on GammaKnife |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient with disabling essential tremor, dystonic and / or parkinsonian in one or more limbs superiors ;
- patient contraindicated or refusing deep brain stimulation ;
- patient ≥ 18 years old,
- women of childbearing potential must take effective contraception ;
- signature of informed consent ; p- atients who benefited from contralateral thalami c stimulation can be included in the study
Key exclusion criteria (7 listed)
- brain irradiation history ;
- contraindication or inability to perform injected MRI ;
- life expectancy <12 months ;
- claustrophobic patient who cannot stand the radiotherapy mask ;
- abnormal anatomy of the thalamic region ;
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 |
|---|---|---|
| Radiosurgical thalamotomy on GammaKnifefractional radiosurgical thalamotomy on an accelerator (3 sessions of 50 Gy at the isocenter ) | Radiation | Radiosurgical thalamotomy on GammaKnife |
Primary outcome
Treatment toxicity
Time frame: 12 months
The treatment will be considered toxic in the event of the appearance, within 12 months after treatment, of non-regressive toxicity of grade> 1 according to the NCI-CTCAE V5.0 scale (symptomatic neurological deficit interfering with daily activities), and that this deficit is related to the treatment.
2 secondary outcomes
Treatment accuracy
Time frame: At 6 and 12 months
Tremor improvement
Time frame: At 3, 6 and 12 months
Results and safety
The study was stopped early (reason given: The treatment at hand was not efficient enough.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. no data sharing is planned
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiosurgical thalamotomy on GammaKnife in people with Essential Tremor and Parkinsonian Disorders, run by Centre Hospitalier Universitaire de Nice at 1 site in Monaco.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 May 2026. 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 Monaco. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The treatment at hand was not efficient enough.). Results are not available in the source record.
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?
Treatment toxicity (time frame: 12 months). 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 26 May 2026.