Cognitive Training After Stroke : Effects and Mechanisms

NCT04932304 | Completed DMC

• 1 other identifier: 2015/1282
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

Stroke is a major cause of severe cognitive and physical disability. Despite the high and increasing incidence, and large health, economic, social and personal consequences, studies designed to remedy cognitive impairments and improve rehabilitation care following stroke are lacking. A promising line of research have shown that weak electrical current (tDCS) can be a safe, cost-effective, and potent treatment when combined with other rehablitational approaches. The underlying mechanism is assumed that tDCS facilitates neuronal signaling, improving plasticity and facilitating rehablitational outcome. But further research is needed to better understand the mechanisms at hand, and to better evaluate the potential clinical utility. The scope for the current project is to investigate both cognitive and neuronal effects of tDCS in combination with cognitive training , with the ultimate goal to improve current rehabilitational healthcare. To achieve this we will use multimodal MRI, EEG, and a comprehensive battery of neuropsychological asessment, to describe and evaluate the effect of tDCS in rehabilitation purposes.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Evidence of change in neural activity in attentional-related brain areas after receiving anodal tDCS, as measured with functional MRI

  Change in activation patterns during multiple object tracking (MOT) at first baseline, before initiating training (second baseline, on average 4 weeks after baseline measure), and after a three-week intervention (post-intervention assessment)

  One and a half year

• Evidence of structural changes after receiving anodal tDCS, as measured with structural MRI

  Structural MRI

  One and a half year

• Evidence of increased attentional and working memory capacity after receiving anodal tDCS

  Rate of improvement in Cogmed tasks

  One and a half year

Secondary Outcomes (1)

• Evidence of increased attentional capacity after receiving anodal tDCS

  One and a half year

Other Outcomes (2)

• Evidence of change in fatigue severity after receiving tDCS

  One and a half year

• Evidence of change in symptoms of depression after receiving tDCS

  One and a half year

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

Participants recieving active trancranial direct current stimulation (tDCS) Parameters: 20 minutes anodal tDCS 1mA. Two times a week, for three weeks. Anode placed at F3, cathode placed at right cerebellum.

Device: Transcranial direct current stimulation (tDCS)

Sham stimulation

PLACEBO COMPARATOR

Participants recieving passive / sham trancranial direct current stimulation (tDCS) Two times a week, for three weeks. Anode placed at F3, cathode placed at right cerebellum.

Device: Sham Transcranial direct current stimulation (tDCS)

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

Active stimulation

Sham Transcranial direct current stimulation (tDCS) DEVICE

Sham Transcranial direct current stimulation (tDCS)

Sham stimulation

Eligibility Criteria

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

You may qualify if:

• \- MR/CT revealing ischemic or hemorrhagic damage (stroke).

You may not qualify if:

• History of illness or damage to the CNS, besides stroke.
• \<18 years of age
• Extensive cognitive decline or dementia
• Severe psychiatric disorders
• Substance or alcohol abuse
• Contraindications for MRI.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (2)

Oslo University Hospital Ullevål

Oslo, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Lars T. Westlye, Ph.D

  University of Oslo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 21, 2021
• Study Start: May 1, 2016
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

NO (2)