Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation

NCT ID: NCT03185234

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-23
• Study Completion Date: 2021-11-09

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.

Detailed Description

Despite the high incidence of the motor cognitive deficit apraxia after left-hemispheric stroke, evidence-based therapies do not exist. This randomized controlled clinical trial (RCT) investigates whether anodal transcranial direct current stimulation (tDCS) as an add-on therapy during neuro-rehabilitation can ameliorate apraxic deficits in patients with left hemisphere stroke. Therefore, anodal tDCS is applied over the parietal cortex of the left, lesioned hemisphere with an intensity of 2 mA for 10 minutes at a time on 5 consecutive days in combination with motor tasks before and after the stimulation. The effect of the stimulation is compared to a sham stimulation. Moreover, application of a pre-programmed study mode ensures a double-blind study design (patient and investigator). The performance in the apraxia test KAS (Cologne Apraxia Screening) 3-4 days after the last stimulation, compared to baseline, serves as primary endpoint of the study. Secondary endpoints are evaluated using various apraxia tests, motor tests and neuropsychological tests 3-4 days after the last stimulation and 3 months after enrollment.

Conditions

Stroke; Apraxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Real tDCS

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.

Group Type: ACTIVE_COMPARATOR

anodal tDCS

Intervention Type: DEVICE

2 mA, 10 min, 5 sessions

Sham tDCS

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.

Group Type: SHAM_COMPARATOR

sham tDCS

Intervention Type: DEVICE

sham stimulation, 10 min, 5 sessions

Interventions

anodal tDCS

2 mA, 10 min, 5 sessions

Intervention Type: DEVICE

sham tDCS

sham stimulation, 10 min, 5 sessions

Intervention Type: DEVICE

Other Intervention Names

neuroConn DCS, model no. 008; neuroConn DCS, model no. 008

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• pregnancy, breastfeeding and women without exclusion of pregnancy
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Gereon R. Fink

Univ.-Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gereon R. Fink, Univ-Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Cologne

Locations

Rehabilitationszentrum Godeshöhe e.V.

Bonn, North Rhine-Westphalia, Germany

MediClin Fachklinik Rhein/Ruhr für Neurologie

Essen, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 33324913 (View on PubMed)

Other Identifiers

U1111-1195-2536

Identifier Type: OTHER

Identifier Source: secondary_id

DRKS00012292

Identifier Type: REGISTRY

Identifier Source: secondary_id

Uni-Koeln-3033

Identifier Type: -

Identifier Source: org_study_id