Primary Orthostatic TremorSTOPNCT02978924
Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor
A study testing tsDCS in people with Primary Orthostatic Tremor, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
To explore the effect of cathodal tsDCS vs sham tsDCS in primary orthostatic tremor. The investigators hypothesize that cathodal tsDCS but not sham tsDCS would be able to restore both motor and sensory pathways of the spinal cord leading to functional improvements. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Primary Orthostatic Tremor
- What is being tested?
- tsDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2017to 28 Nov 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with POT diagnosed since at least 1 year
- Normal neurological examination with the exception of POT
- Patients with or without treatment for TOP, or with treatment not sufficiently effective
- Affiliated with the French social security scheme, universal medical coverages (CMU), or an equivalent scheme
- Signed informed consent
Who cannot join
- Psychiatric or neurological conditions (with the exception of POT)
- Presence of potential tsDCS risk factors including an electrically, magnetically or mechanically activated implant (including cardiac pacemaker, epidural stimulation electrodes, etc.), an intravascular clip or any other electrically sensitive support system, damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
- Presence of TMS risk factor including cardiac pacemaker, history of epilepsy, traumatic brain injury with loss of consciousness, intracerebral clips, cochlear or ocular implants
- Pregnancy in women (as determined by a urine pregnancy test in pre-menopausal women), or lactating women or women planning pregnancy during the course of the study
- Patients enrolled in another biomedical research at the time of the study
- Participant who does not wish to be informed of any clinically relevant abnormalities (as determined by the investigators) identified during the course of the study
- Patient under guardianship or curatorship, or under judicial supervision
Trial locations and contacts
1 site in 1 country.
About this study
To explore the effect of cathodal tsDCS vs sham tsDCS in primary orthostatic tremor. The investigators hypothesize that cathodal tsDCS but not sham tsDCS would be able to restore both motor and sensory pathways of the spinal cord leading to functional improvements.
Read the detailed description
Regain of function and improvement of motor skills is a major challenge in motor disorders in which spinal cord functions play a key role. The growing development of non-invasive brain stimulations in the past decade led to significant progress in the understanding of neuronal abnormalities in patients with movement disorders that opens up new vistas for experimental treatments. However, these treatments are currently limited due to their high cost and lack of possibility to use in outpatients. Recently, trans-spinal direct current stimulation (tsDCS) has emerged as a novel tool to modulate non-invasively spinal cord excitability. This may be an excellent alternative to epidural stimulation, the sole technique available up to now to alter spinal functions in an invasive fashion. The overall goal of this study is to assess the potential of tsDCS to restore spinal cord functions in patients with primary orthostatic tremor (POT), a disorder with little or no current therapeutic resources and high disability for patients.
Using a crossover, randomized, double-blinded approach, cathodal (2mA, 20 min) or sham tsDCS (with the active electrodes over the thoracic level and the reference electrode on the right shoulder) will be delivered to 15 patients with POT. The maximal time in upright position determined by a force platform, the cortical excitability assessed by transcranial magnetic stimulation (input / output curve of the tibialis anterior muscle and short-latency afferent inhibition) and EMG activities of lower extremity muscles will be measured before (PRE), immediately and 30 minutes after current offset (POST0 and POST30 respectively). Cathodal and sham tsDCS will be delivered in two different sessions with a washout period of at least 7 days. The investigators anticipate that cathodal tsDCS but not sham tsDCS will be able to modulate both sensory and motor functions in POT and will, in turn, lead to functional improvement.
- Conditions
- Primary Orthostatic Tremor
- Being tested
- tsDCS
- Keywords
- spinal cord, tsDCS, 3D motion capture, EMG
- Medical subject headings
- Primary orthostatic tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tsDCSDevice
20 min of treatment applied at the thoracic level (active electrode) with reference placed on the right shoulder
| Study group | Role | What they receive |
|---|---|---|
| Cathodal tsDCS | Active comparator | 20 min of active treatment Receives: Device: tsDCS |
| Sham tsDCS | Sham comparator | 20 min of sham treatment Receives: Device: tsDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal time in the upright position without support
Force plateform
Measured: Before (PRE) and immediately after current offset (POST0)
Secondary outcomes (2)
Quantitative assessment of tremor (EMG)
Measured: Before (PRE), immediately after (POST0) and 30min (POST30) current offset
Cortical excitability assessed by Transcranial Magnetic Stimulation
Measured: Before (PRE), immediately after (POST0) and 30min (POST30) current offset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start17 Jan 2017
- Primary completionNov 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Orthostatic TremorStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marie Vidailhet, MD, Principal investigator, marie.vidailhet@psl.aphp.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978924
- Sponsor's protocol ID
- C16-26
- Other IDs
- 2016-A01202-49
- Acronym
- STOP
- Status last verified
- Aug 2021
- First submitted
- 22 Nov 2016
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lamy JC, Varriale P, Apartis E, Mehdi S, Blancher-Meinadier A, Kosutzka Z, Degos B, Frismand S, Simonetta-Moreau M, Meunier S, Roze E, Vidailhet M. Trans-Spinal Direct Current Stimulation for Managing Primary Orthostatic Tremor. Mov Disord. 2021 Aug;36(8):1835-1842. doi: 10.1002/mds.28581. Epub 2021 Mar 27.
PubMed 33772851
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor
- ClinicalTrials.gov ID
- NCT02978924
- Acronym / sponsor ID
- STOP / C16-26
- Conditions
- Primary Orthostatic Tremor
- Keywords
- spinal cord, tsDCS, 3D motion capture, EMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 1 Dec 2016 (estimated)
- 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.
To explore the effect of cathodal tsDCS vs sham tsDCS in primary orthostatic tremor. The investigators hypothesize that cathodal tsDCS but not sham tsDCS would be able to restore both motor and sensory pathways of the spinal cord leading to functional improvements.
Detailed description
Regain of function and improvement of motor skills is a major challenge in motor disorders in which spinal cord functions play a key role. The growing development of non-invasive brain stimulations in the past decade led to significant progress in the understanding of neuronal abnormalities in patients with movement disorders that opens up new vistas for experimental treatments. However, these treatments are currently limited due to their high cost and lack of possibility to use in outpatients. Recently, trans-spinal direct current stimulation (tsDCS) has emerged as a novel tool to modulate non-invasively spinal cord excitability. This may be an excellent alternative to epidural stimulation, the sole technique available up to now to alter spinal functions in an invasive fashion. The overall goal of this study is to assess the potential of tsDCS to restore spinal cord functions in patients with primary orthostatic tremor (POT), a disorder with little or no current therapeutic resources and high disability for patients.
Using a crossover, randomized, double-blinded approach, cathodal (2mA, 20 min) or sham tsDCS (with the active electrodes over the thoracic level and the reference electrode on the right shoulder) will be delivered to 15 patients with POT. The maximal time in upright position determined by a force platform, the cortical excitability assessed by transcranial magnetic stimulation (input / output curve of the tibialis anterior muscle and short-latency afferent inhibition) and EMG activities of lower extremity muscles will be measured before (PRE), immediately and 30 minutes after current offset (POST0 and POST30 respectively). Cathodal and sham tsDCS will be delivered in two different sessions with a washout period of at least 7 days. The investigators anticipate that cathodal tsDCS but not sham tsDCS will be able to modulate both sensory and motor functions in POT and will, in turn, lead to functional improvement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cathodal tsDCS | Active comparator | Device: tsDCS20 min of active treatment |
| Sham tsDCS | Sham comparator | Device: tsDCS20 min of sham treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with POT diagnosed since at least 1 year
- Normal neurological examination with the exception of POT
- Patients with or without treatment for TOP, or with treatment not sufficiently effective
- Affiliated with the French social security scheme, universal medical coverages (CMU), or an equivalent scheme
- Signed informed consent
Key exclusion criteria (7 listed)
- Psychiatric or neurological conditions (with the exception of POT)
- Presence of potential tsDCS risk factors including an electrically, magnetically or mechanically activated implant (including cardiac pacemaker, epidural stimulation electrodes, etc.), an intravascular clip or any other electrically sensitive support system, damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
- Presence of TMS risk factor including cardiac pacemaker, history of epilepsy, traumatic brain injury with loss of consciousness, intracerebral clips, cochlear or ocular implants
- Pregnancy in women (as determined by a urine pregnancy test in pre-menopausal women), or lactating women or women planning pregnancy during the course of the study
- Patients enrolled in another biomedical research at the time of the study
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 |
|---|---|---|
| tsDCS20 min of treatment applied at the thoracic level (active electrode) with reference placed on the right shoulder | Device | Cathodal tsDCS, Sham tsDCS |
Primary outcome
Change in maximal time in the upright position without support
Time frame: Before (PRE) and immediately after current offset (POST0)
Force plateform
2 secondary outcomes
Quantitative assessment of tremor (EMG)
Time frame: Before (PRE), immediately after (POST0) and 30min (POST30) current offset
Cortical excitability assessed by Transcranial Magnetic Stimulation
Time frame: Before (PRE), immediately after (POST0) and 30min (POST30) current offset
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 2 Sep 2025.
- Results publication: PubMed 33772851Lamy JC, Varriale P, Apartis E, Mehdi S, Blancher-Meinadier A, Kosutzka Z, Degos B, Frismand S, Simonetta-Moreau M, Meunier S, Roze E, Vidailhet M. Trans-Spinal Direct Current Stimulation for Managing Primary Orthostatic Tremor. Mov Disord. 2021 Aug;36(8):1835-1842. doi: 10.1002/mds.28581. Epub 2021 Mar 27.
- Individual participant dataSharing planned: No
Related trials for Primary Orthostatic Tremor
Active, not recruiting
Modulating Cerebellar Activity With Low-intensity Focused Ultrasound Stimulation for Primary Orthostatic Tremor
Orthostatic Tremor
Recruiting
The Use of the CUE1/CUE1+ in People With Parkinson's Disease and Related Disorders
Parkinson's Disease and Parkinsonism, Progressive Supranuclear Palsy
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.
Marie Vidailhet, MD principal investigator
marie.vidailhet@psl.aphp.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tsDCS in people with Primary Orthostatic Tremor, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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: finished, as of the sponsor's last update on 2 Sep 2025. 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 France. 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 maximal time in the upright position without support (time frame: Before (PRE) and immediately after current offset (POST0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02978924, which also lists 1 linked publication.
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 2 Sep 2025.