NCT02978924

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 17, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2017

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

November 22, 2016

Last Update Submit

August 25, 2025

Conditions

Primary Orthostatic Tremor

Keywords

spinal cordtsDCS3D motion captureEMG

Outcome Measures

Primary Outcomes (1)

  • Change in maximal time in the upright position without support

    Force plateform

    Before (PRE) and immediately after current offset (POST0)

Secondary Outcomes (2)

  • Quantitative assessment of tremor (EMG)

    Before (PRE), immediately after (POST0) and 30min (POST30) current offset

  • Cortical excitability assessed by Transcranial Magnetic Stimulation

    Before (PRE), immediately after (POST0) and 30min (POST30) current offset

Study Arms (2)

Cathodal tsDCS

ACTIVE COMPARATOR

20 min of active treatment

Device: tsDCS

Sham tsDCS

SHAM COMPARATOR

20 min of sham treatment

Device: tsDCS

Interventions

tsDCSDEVICE

20 min of treatment applied at the thoracic level (active electrode) with reference placed on the right shoulder

Cathodal tsDCSSham tsDCS

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre investigation clinique

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 33772851BACKGROUND

MeSH Terms

Conditions

Primary orthostatic tremor

Study Officials

  • Marie Vidailhet, MD

    marie.vidailhet@psl.aphp.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2016

First Posted

December 1, 2016

Study Start

January 17, 2017

Primary Completion

November 1, 2017

Study Completion

November 28, 2017

Last Updated

September 2, 2025

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)