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

NCT ID: NCT05466487

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-21
• Study Completion Date: 2023-03-24

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

Study Design

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

Study Groups

Active tACS

Group Type: EXPERIMENTAL

Transcranial Alternating Current Stimulation (tACS)

Intervention Type: 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.

Visual Scanning Training (VST)

Intervention Type: 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.

Sham tACS

Group Type: SHAM_COMPARATOR

Transcranial Alternating Current Stimulation (tACS)

Intervention Type: 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.

Visual Scanning Training (VST)

Intervention Type: 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.

Interventions

Transcranial Alternating Current Stimulation (tACS)

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.

Intervention Type: DEVICE

Visual Scanning Training (VST)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander T. Sack, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Maastricht University

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 39301290 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36324088 (View on PubMed)

Other Identifiers

NL70256.068.19

Identifier Type: -

Identifier Source: org_study_id