Noninvasive Brain Stimulation for Stroke

Stroke Clinical Trial

— NIBSstroke  

Official title:

Noninvasive Brain Stimulation for Stroke Improvement

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01503073
• Other study ID #: B03920073136
• Status: Suspended
• Phase: N/A
• Start date: January 2008
• Est. completion date: December 2030

Study information

• Verified date: May 2023
• Source: University Hospital of Mont-Godinne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a variety of functions.

Description:

Noninvasive brain stimulations (NIBS) will be used in acute and chronic stroke patients to improve a variety of functions such as motor functions, cognitive functions, ...

NIBS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after NIBS, as well as brain functional imaging data.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• stroke with at least slight deficit

Exclusion Criteria:

• epilepsy

• contraindication to tDCS and/or to fMRI

• presence of metal in the head

• unability to understand / complete behavioural tasks

• chronic intake of alcohol or recreative drugs

• major health condition

• presence of pacemaker

• pregnancy

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
transcranial direct current stimulation

Locations

Country	Name	City	State
Belgium	Department of Neurology, CHU Mont-Godinne	Yvoir	Namur

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Mont-Godinne

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in function before/after tDCS	any brain function impaired by stroke	Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months
Secondary	change in neuroimaging and neurophysiological before/after tDCS	noninvasive neuroimaging : brain activity studied by means of fMRI; noninvasive neurophysiological measure : TMS, EEG,evoked potentials, EMG	Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months