Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation

NCT03185234 | Completed DMC

• 3 other identifiers: Uni-Koeln-3033U1111-1195-2536DRKS00012292
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the clinical trial is to investigate whether weak transcranial direct current stimulation (tDCS) can ameliorate the motor cognitive deficit apraxia during stroke rehabilitation. Stroke patients with apraxia will either receive a real stimulation or a sham stimulation (placebo) for 10 minutes at a time on 5 consecutive days during their in-patient stay in a rehabilitation center. Additionally, motor tasks are performed before and after the stimulation. The effect of the weak current stimulation on motor function is assessed 3-4 days after the last stimulation and 3 months after enrollment.

Conditions

Stroke; Apraxia

Keywords

tDCS

Outcome Measures

Primary Outcomes (1)

• KAS (Cologne Apraxia Screening)

  Degree of apraxia

  3-4 days after stimulation

Secondary Outcomes (11)

• KAS (Cologne Apraxia Screening)

  3 months after enrollment

• Goldenberg Imitation

  3-4 days after stimulation, and 3 months after enrollment

• de Renzi Imitation

  3-4 days after stimulation, and 3 months after enrollment

• de Renzi actual tool use

  3-4 days after stimulation, and 3 months after enrollment

• Action Research Arm Test (ARAT)

  3-4 days after stimulation, and 3 months after enrollment

Study Arms (2)

Real tDCS

ACTIVE COMPARATOR

Anodal tDCS at an intensity of 2 mA is applied for 10 minutes at a time on 5 consecutive days. The anodal electrode is placed over the left parietal cortex (P3 in 10/20 EEG) of the lesioned hemisphere, the cathodal electrode is located supraorbital on the right side. Motor tasks are performed before and after the stimulation.

Device: anodal tDCS

Sham tDCS

SHAM COMPARATOR

Sham stimulation is applied for 10 minutes at a time on 5 consecutive days. One electrode is placed over the left parietal cortex (P3 in 10/20 EEG) of the lesioned hemisphere and a second electrode supraorbital on the right side. Motor tasks are performed before and after the stimulation.

Device: sham tDCS

Interventions

anodal tDCS DEVICE

2 mA, 10 min, 5 sessions

Also known as: neuroConn DCS, model no. 008

Real tDCS

sham tDCS DEVICE

sham stimulation, 10 min, 5 sessions

Also known as: neuroConn DCS, model no. 008

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• left hemispheric ischemic stroke in the subacute/ chronic phase (\>10 days and \<180 days post-stroke)
• clinical confirmation of apraxia by KAS (Cologne Apraxia Screening), Cut-off ≤ 76/ 80 points;
• age 18 - 90 years;
• written Informed Consent

You may not qualify if:

• patients with clinical manifestation of a stroke prior to the index-stroke
• malignant disease with affection of central nervous system
• life expectancy \<12 months
• current addiction to alcohol or drugs or other addictive disease (exception: nicotine)
• current clinically manifest psychiatric disorders, such as schizophrenia or severe depressive episode
• epileptic seizure within the past two years
• continuous medication during the intervention phase with benzodiazepine, antipsychotics of high potential and anti-epileptic drugs taken for prophylaxis of epileptic seizures
• enrollment in other studies with brain stimulation in the time period after the index stroke
• heart pacemaker
• electrodes for deep brain stimulation or other metal implants in the head (expected are dental fillings and inlays)
• craniectomy or trepanation
• vulnerable skin lesions at electrode positions
• poor motivation/ cooperation

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (2)

Rehabilitationszentrum Godeshöhe e.V.

Bonn, North Rhine-Westphalia, 53177, Germany

Location

MediClin Fachklinik Rhein/Ruhr für Neurologie

Essen, North Rhine-Westphalia, 45219, Germany

Location

Related Publications (1)

• Kleineberg NN, Richter MK, Becker I, Weiss PH, Fink GR. Verum versus sham tDCS in the treatment of stroke-induced apraxia: study protocol of the randomized controlled trial RAdiCS -"Rehabilitating (stroke-induced) Apraxia with direct Current Stimulation". Neurol Res Pract. 2020 Mar 4;2:7. doi: 10.1186/s42466-020-0052-y. eCollection 2020.

  PMID: 33324913 DERIVED

MeSH Terms

Conditions

Stroke; Apraxias

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Gereon R. Fink, Univ-Prof.

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 14, 2017
• Study Start: June 23, 2017
• Primary Completion: July 13, 2021
• Study Completion: November 9, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)