Non-Invasive Brain Stimulation as an Innovative Treatment for Chronic Neglect Patients

NCT05466487 | Completed

• 1 other identifier: NL70256.068.19
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Background Stroke is a leading cause of neurological impairments in language, motor and cognitive functions. Next to traditional stroke treatment, Non-Invasive Brain Stimulation (NIBS) offers the potential to facilitate stroke recovery as a complementary approach. Here, we aim at exploiting the principles of NIBS, specifically transcranial Alternating Current Stimulation (tACS), to promote functional recovery of people with neglect symptoms following stroke. Objective To determine whether neglect training complemented with tACS treatment in chronic stroke patients suffering from neglect improves neglect-related symptoms compared to neglect training with sham stimulation. Study design Double-blind randomized placebo-controlled intervention study. After enrollment and completion of baseline measurements, participants are randomly assigned to either the active tACS group or sham (control) group. Intervention We will combine an evidence based visual scanning training (VST) with 40 minutes of (active or sham) tACS at alpha frequency. The intervention is administered three times a week for a duration of six weeks. Outcomes of the study Performance on standard, conventional neuropsychological tests, as well as on ADL observation scales.

Conditions

Spatial Neglect

Outcome Measures

Primary Outcomes (1)

• Star Cancellation Task

  Quality of search score

  Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.

Secondary Outcomes (6)

• Computerized Visual Detection Task

  Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.

• McIntosh Line Bisection Task-digitized

  Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.

• Schenkenberg Line Bisection Task

  Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.

• Baking Tray Task

  Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.

• Catherine Bergego Scale

  Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.

Other Outcomes (1)

• EEG

  Testing will take place before the training (T0; baseline), and after the eighteenth (T3) training session.

Study Arms (2)

Active tACS

EXPERIMENTAL

Device: Transcranial Alternating Current Stimulation (tACS); Behavioral: Visual Scanning Training (VST)

Sham tACS

SHAM COMPARATOR

Device: Transcranial Alternating Current Stimulation (tACS); Behavioral: Visual Scanning Training (VST)

Interventions

Transcranial Alternating Current Stimulation (tACS) DEVICE

Stimulation frequency and peak-to-peak intensity will be set to 10Hz and 1.5 milliampere (mA), phase offset will be set to 0 and 100 cycles will be used for ramping up. At the start of the neglect training session, the tACS will be started. When the neglect training session is finished, after maximally 40 minutes, the tACS will be switched off.

Active tACS; Sham tACS

Visual Scanning Training (VST) BEHAVIORAL

The most common treatment for neglect is VST, which is an intensive compensation training (see Dutch guidelines for rehabilitation of neglect: Ten Brink, Van Kessel, \& Nijboer, 2017). The aim of this training is to improve visual scanning behavior, that is, to encourage neglect patients to actively and consciously pay attention to stimuli on the contralesional side.

Active tACS; Sham tACS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• neurologically objectified stroke;
• stroke occurred when patient was 18-80 years of age;
• chronic stroke (\>6 months post-stroke onset);
• sufficient comprehension and communication skills to benefit from training (based on clinical judgement); and
• a screening containing four neuropsychological tests will be performed to evaluate the current severity of the neglect, since the diagnosis of neglect may have been established months or even years ago in our sample of chronic stroke patients.

You may not qualify if:

• currently engaging in cognitive rehabilitation treatment or neglect treatment;
• physically or mentally unable to participate (based on clinical judgment);
• hemianopsia (based on clinical judgement);
• severe communicative disability, as task descriptions need to be understood;
• local scalp injuries\*;
• eczema on scalp or psoriasis\*;
• diagnosed (neuro)psychiatric or neurodegenerative diseases\*;
• current alcohol and/or drug abuse\*; and
• pregnancy\*.
• due to tACS safety considerations.

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (2)

• Middag-van Spanje M, Nijboer TCW, Schepers J, van Heugten C, Sack AT, Schuhmann T. Alpha transcranial alternating current stimulation as add-on to neglect training: a randomized trial. Brain Commun. 2024 Aug 30;6(5):fcae287. doi: 10.1093/braincomms/fcae287. eCollection 2024.

  PMID: 39301290 DERIVED

• Middag-van Spanje M, Schuhmann T, Nijboer T, van der Werf O, Sack AT, van Heugten C. Study protocol of transcranial electrical stimulation at alpha frequency applied during rehabilitation: A randomized controlled trial in chronic stroke patients with visuospatial neglect. BMC Neurol. 2022 Nov 2;22(1):402. doi: 10.1186/s12883-022-02932-7.

  PMID: 36324088 DERIVED

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

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

Study Officials

• Alexander T. Sack, PhD

  Maastricht University

  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: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 20, 2022
• Study Start: October 21, 2020
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)