Combine Mirror Therapy and tDCS on CPSP

NCT05119881 | Completed

• 1 other identifier: 202003063DINC
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Central poststroke pain (CPSP) refers to the symptom of pain arising after a stroke. Patients with CPSP often complain of various painful or unpleasant sensation. Feelings of pain may interfere with sleep and hugely affect the patients' quality of life. Non-invasive brain stimulation, such as transcranial direct current stimulation (tDCS), is an emerging nonpharmacological treatment and has been shown to have promising pain reduction effects for patients with CPSP. Mirror therapy (MT), on the other hand, is a contemporary approach that has often been used to facilitate upper extremity motor recovery in patients with stroke. MT has been shown to be effective in ameliorating sensory deficits and reducing shoulder pain. To date, no study has determined whether combining MT with tDCS could reduce pain in patients with CPSP. The goal of this study is to determine the effect of combining MT and tDCS on pain, sensation, motor function, and quality of life in people with CPSP. Forty-five patients with CPSP will be randomly allocated to one of the 3 groups: combining MT with tDCS (MT+tDCS) group, MT with sham tDCS (MT+s-tDCS) group, and sham MT with tDCS (s-MT+tDCS) group. The participants in all groups will receive intervention 30 minutes/day, 3 days/ week, for 3 weeks. The participants in the MT+tDCS group will receive tDCS applied simultaneously with MT for 20 minutes. For the following 10 minutes, the tDCS will be turned off while the electrodes will be kept on the scalp, and the participants will continue with MT. For the MT+s-tDCS group, same tDCS procedures will be applied to the participants except that the stimulator will be turned off within 30 seconds. As for the s-MT+tDCS group, the participants will receive the same tDCS procedure as the MT+tDCS group while a sham MT condition will be applied. Clinical and neurophysiological assessments will be conducted before the treatment (pretest), after 3 weeks of treatment (post-test), and 1 month after the treatment (follow-up test). The assessments will be performed by research assistants who will be blinded to the group allocation of the participants. Mix-model Group × Time repeated measures ANOVAs will be used to determine the intervention effects of the 3 groups.

Conditions

Stroke; Pain

Keywords

central poststroke pain; mirror therapy; transcranial direct current stimulation; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Change in subjective pain assessed by VAS

  Visual analog scale (VAS) will be used to measure subjective pain intensity. The participants will be required to mark their pain level on a 10 cm line without gradations. The distance from the starting point to the point that the patient marked will be converted into a pain score. While 0 indicates no pain at all, and 10 suggests unbearable pain. Subjective pain will be assessed at pre-test, post-test, and follow-up test, and trend of change will be determined.

  3 time points: before treatment (pre-test), after 3 weeks of treatment (post-test), 1 month after the treatment (follow-up test)

Secondary Outcomes (11)

• Change in Mini-Mental Screening Examination (MMSE)

  3 time points: before treatment (pre-test), after 3 weeks of treatment (post-test), 1 month after the treatment (follow-up test)

• Change in pressure pain threshold

  3 time points: before treatment (pre-test), after 3 weeks of treatment (post-test), 1 month after the treatment (follow-up test)

• Change in Neuropathic pain symptom inventory (NPSI)

  3 time points: before treatment (pre-test), after 3 weeks of treatment (post-test), 1 month after the treatment (follow-up test)

• Change in Quantitative sensory test (QST)

  3 time points: before treatment (pre-test), after 3 weeks of treatment (post-test), 1 month after the treatment (follow-up test)

• Change in Fugl-Mayer Assessment-Upper Extremity (UE-FMA)

  3 time points: before treatment (pre-test), after 3 weeks of treatment (post-test), 1 month after the treatment (follow-up test)

Study Arms (3)

MT+tDCS

EXPERIMENTAL

The participants will receive mirror therapy combined with real transcranial direct current stimulation.

Behavioral: mirror therapy; Device: tDCS

MT+sham tDCS

ACTIVE COMPARATOR

The participants will receive mirror therapy combined with sham transcranial direct current stimulation.

Behavioral: mirror therapy; Device: sham tDCS

sham MT + tDCS

ACTIVE COMPARATOR

The participants will receive sham mirror therapy combined with real transcranial direct current stimulation.

Device: tDCS; Behavioral: sham mirror therapy

Interventions

mirror therapy BEHAVIORAL

a mirror box will be placed in front of the participants with the mirror reflection side toward the non-paretic limb. The paretic arm will be placed behind the mirror, and the mirror box will block the vision of the paretic limb. Through this method, the patients can only view the movement of the non-paretic limb and its mirror reflection from the mirror. The participants will be instructed to move or perform functional tasks with their non-paretic limb and look at the mirror reflection of the non-paretic limb and mentally imagine that it is the paretic arm moving. At the same time, the participants will be encouraged to move the paretic arm along with the mirror reflection of the non-paretic arm. Activities practice during MT will include gross motor movements, fine motor movements, and functional tasks.

MT+sham tDCS; MT+tDCS

tDCS DEVICE

The tDCS will be delivered by a DC-stimulator (Soterix Medical Inc, New York, USA) through 2 saline-soaked surface sponge electrodes (anodal electrode size: 25 cm2; cathode electrode size: 25 cm2). The anodal electrode will be placed over the ipsilesional M1 while the cathodal electrode will be placed over the contralesional M1. The stimulation intensity will be ramped up to 2mA in 15 seconds, and maintained at 2mA throughout the 20-minute stimulation for the MT+tDCS group.

MT+tDCS; sham MT + tDCS

sham mirror therapy BEHAVIORAL

For the sham MT (s-MT) condition, the same mirror box will be used except that the mirror side will be made blurred to view; thus, the participants will not be able to view the mirror reflection of the paretic limb. The participants will perform the same activities as the real MT condition.

sham MT + tDCS

sham tDCS DEVICE

For the sham tDCS group, the electrodes will be placed on the brain regions as the real tDCS group. The intensity will first be ramped up to 2mA within 15 seconds and then the stimulator will be turned off gradually within the next 30 seconds.

MT+sham tDCS

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) age ranges from 20 to 90 years old,
• (2) history of unilateral ischemic or hemorrhagic stroke for more than 6 months,
• (3) without severe weakness on affected side and able to catch things with affected hand,
• (4) have neuropathic pain and/or sensory deficits occurring in the hemiplegic extremity (Visual Analog Scale ≥ 3), and
• (5) do not have cognitive impairment (Mini-Mental State Examination ≥ 24).

You may not qualify if:

• (1) pain caused by reflex sympathetic dystrophy, peripheral neuropathy, structural lesions or due to psychological issues,
• (2) a personal history of seizure or family history of epilepsy,
• (3) metal implanted in the brain,
• (4) implanted pacemaker,
• (5) history of neurological or psychological diseases other than stroke,
• (6) a history of head surgery or brain injury,
• (7) unstable migraine or tinnitus that is not under medication control,
• (8) aphasia,
• (9) pregnancy or breastfeeding,
• (10) poor response to present medication,
• (11) under medication that may influence central nerve system (e.g. reducing threshold of seizure),
• (12) skin sensitive to the application of electrical current,
• (13) sleep deprivation, or
• (14) severe or recent heart diseases.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, 10055, Taiwan

Location

MeSH Terms

Conditions

Stroke; Pain

Interventions

Mirror Movement Therapy; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sung-Chun Tang, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Ya-Yun Lee, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher(s) who perform the outcome assessments will be blinded to the group allocation of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 groups of different interventions

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 15, 2021
• Study Start: October 12, 2021
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)