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Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor (STOP)

Primary Purpose

Primary Orthostatic Tremor

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tsDCS
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Primary Orthostatic Tremor focused on measuring spinal cord, tsDCS, 3D motion capture, EMG

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Centre investigation clinique

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Cathodal tsDCS

Sham tsDCS

Arm Description

20 min of active treatment

20 min of sham treatment

Outcomes

Primary Outcome Measures

Change in maximal time in the upright position without support
Force plateform

Secondary Outcome Measures

Quantitative assessment of tremor (EMG)
Cortical excitability assessed by Transcranial Magnetic Stimulation

Full Information

First Posted
November 22, 2016
Last Updated
August 24, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02978924
Brief Title
Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor
Acronym
STOP
Official Title
Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Orthostatic Tremor
Keywords
spinal cord, tsDCS, 3D motion capture, EMG

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cathodal tsDCS
Arm Type
Active Comparator
Arm Description
20 min of active treatment
Arm Title
Sham tsDCS
Arm Type
Sham Comparator
Arm Description
20 min of sham treatment
Intervention Type
Device
Intervention Name(s)
tsDCS
Intervention Description
20 min of treatment applied at the thoracic level (active electrode) with reference placed on the right shoulder
Primary Outcome Measure Information:
Title
Change in maximal time in the upright position without support
Description
Force plateform
Time Frame
Before (PRE) and immediately after current offset (POST0)
Secondary Outcome Measure Information:
Title
Quantitative assessment of tremor (EMG)
Time Frame
Before (PRE), immediately after (POST0) and 30min (POST30) current offset
Title
Cortical excitability assessed by Transcranial Magnetic Stimulation
Time Frame
Before (PRE), immediately after (POST0) and 30min (POST30) current offset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Vidailhet, MD
Organizational Affiliation
marie.vidailhet@psl.aphp.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre investigation clinique
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor

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