tDCS in Acute Stroke Patients

NCT02806856 | Unknown DMC

• 1 other identifier: D16-P04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Very early after the onset of the focal perfusion deficit, excitotoxic mechanisms can lethally damage neurons and glia. Excitotoxicity triggers a number of events that can further contribute to tissue death. Such events include peri-infarct depolarizations (PID) and cortical spreading depolarization (CSD) within the peri-infarct zone or ischaemic penumbra. Noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) are emerging as promising tools, owing to their effects on modulating cortical activity. Experimental studies have indicated that cathodic polarization of the cortical surface blocks initiation of CSD. Moreover, it has been recently demonstrated in murine stroke models that cathodal tDCS exerts a measurable neuroprotective effect in the acute phase of stroke, decreasing the number of spreading depolarizations and reducing the infarct volume by 20 to 30%. The investigators propose here a pilot study, in acute middle cerebral artery stroke patients, with a double blind randomization: cathodal tDCS versus sham tDCS. The duration of this study will be two years. Fifty acute middle cerebral artery stroke patients will be included. The tDCS will begin within 4.5 hours of symptom onset. The main criteria of evaluation will be the extent of diffusion-weighted imaging (DWI) infarct volume between imaging on admission and 24 hours later. The investigators propose the hypothesis that in acute stroke patients, cathodal tDCS could be an adjuvant approach to recanalizing therapies.

Conditions

Acute Stroke

Keywords

Middle Cerebral Artery Stroke; tDCS; Acute

Outcome Measures

Primary Outcomes (1)

• Brain MRI diffusion weighted images

  Brain MRI, diffusion weighted images will be used. The objective in this study is to use infarct growth attenuation as an end-point. MRI infarct growth (IG) will be determined by the subtraction of acute from follow-up (day 1) diffusion-weighted imaging (DWI) lesion volumes, measured in mL (Forkert et al, 2013; Hassen et al, 2016).

  Day 1

Secondary Outcomes (6)

• NIHSS

  Day 7

• Rankin scale

  3 months

• tDCS safety

  Each hour during 6 hours

• tDCS safety

  Day 1

• tDCS tolerability

  Each hour during 6 hours

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Device: tDCS neuroConn

Sham

SHAM COMPARATOR

Device: Sham stimulation

Interventions

tDCS neuroConn DEVICE

Cathodal on M1

Active tDCS

Sham stimulation DEVICE

Sham

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• middle cerebral artery stroke confirmed by MRI
• neuroradiology: initial MRI with diffusion and perfusion sequences
• NIHSS scale between 4 and 25
• delay since the beginning of symptoms \< 4h30
• intravenous thrombolysis treatment
• obtained consent
• patient affiliated or benefiting from the French national insurance

You may not qualify if:

• pregnant woman
• contraindications for an MRI scan : heart pace-maker, patients who have a metallic foreign body (metal sliver) in their eye or in their brain.
• contraindications for the tDCS : scalp or forehead cutaneous lesion, history of intra-cranial surgery
• coma
• beginning of the symptoms cannot be precisely specified

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Centre Hospitalier Sainte Anne

Paris, 75674, France

RECRUITING

MeSH Terms

Conditions

Stroke; Infarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Martine GAVARET, MD, PhD

  Université Paris Descartes

  STUDY DIRECTOR

• Jean-Louis MAS, professor

  CHSA INSERM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine GAVARET, MD, PhD

CONTACT

00 33 6 08 21 04 22; martine.gavaret@parisdescartes.fr

Marie GODARD

CONTACT

00 33 1 45 65 77 28; marie.godard@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: June 21, 2016
• Study Start: January 26, 2017
• Primary Completion: October 1, 2018
• Study Completion: February 1, 2019
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)