Acu-TENS to Improve the Sleep Quality in People with Stroke

Official title

Transcutaneous Electrical Nerve Stimulation (TENS) Over Acupoints (Acu-TENS) for Improving Sleep Quality, Cognitive Function, Motor Function and in Post-stroke Patients

Overview

Post-stroke sleep disorder and motor/cognitive dysfunction are common complications that affect the quality of life of older patients. The proposed study investigates the effects of an acupuncture-like method applied to six bilateral acupoints on sleep quality, motor function and cognition in older adults with chronic stroke. The study will be a single-blind (i.e., only patients will be blinded about the research purpose) randomized controlled trial (i.e., patients receiving the treatment is chosen at random) with a pre-mid-post follow-up design and involve two parallel groups of post-stroke survivors (aged \> 55 years) diagnosed with insomnia. Participants will be randomly allocated in a 1:1 radio to two independent groups, i.e., a treatment group or placebo group, namely a transcutaneous electrical nerve stimulation placed on acupoints (Acu-TENS) or a placebo group. The Acu-TENS group will receive a 6-week treatment that includes a 30-minute Acu-TENS + sleep hygiene program (SHP) twice a week. The placebo group will receive sham Acu-TENS (i.e., devices with the electrical circuit disconnected) + SHP with the same frequency as the Acu-TENS group. The selected acupoints will be bilateral Hegu (LI4), Quchi (LI11), Neiguan (PC6), Shenmen (HT7) on the arm and Sanyinjiao (SP6) and Zusanli (ST36) on the lower limb. The study's primary outcomes will be sleep quality measured by the device of ActiGraph and the self-report survey. The secondary outcomes will be motor function, measured by physical performance tests, cognition, measured by computer battery, and quality of life, measured by the self-report survey. All outcomes will be measured at the baseline assessment (before the treatment), mid-term assessment (after the three weeks treatment), post-treatment assessment (after the six-week treatment), and follow-up assessment (two weeks after the treatment ended). It is hypothesized that the Acu-TENS + SHP treatment will better alleviate insomnia, improve cognition and motor function in participants than the sham Acu-TENS + SHP treatment.

Detailed description

The proposed study investigates the effects of non-invasive acupuncture techniques (i.e. transcutaneous electrical nerve stimulation at acupoints; Acu-TENS) applied to six selected bilateral acupoints on sleep quality, motor function and cognition in older adult participants with chronic stroke. This proposed project aims to investigate the effectiveness of Acu-TENS + sleep hygiene program (SHP), compare with placebo-stimulation +SHP on sleep quality, motor function and cognition, and quality of life of older adults with chronic stroke.

Impact:

1. Practical significance: The proposed clinical-based randomized controlled trial will rigorously investigate the effects of Acu-TENS applied to selected acupoints on sleep quality, motor function, cognition, and quality of life in older adults with chronic stroke. The results of this study will shed light on the effectiveness of this non-invasive acupuncture treatment for treating insomnia and improving motor and cognition function in older adults with chronic stroke. This will help healthcare professionals treat this highly prevalent disorder for which effective treatments are currently lacking. 2. Scientific significance: The proposed study will be the first to investigate the effects of Acu-TENS on elderly patients with post-stroke insomnia. The objective measures used in the rigorously designed study will generate high-quality data and produce rigorous results.

Interventions

• Device Acu-TENS
  A dual-channel TENS stimulator will be used (ECS300A; Neurotrac, Verity Medical LTD, Ireland). Electrodes will be placed over selected acupoints (i.e., bilateral Sanyinjiao (SP6), Neiguan (PC6), Shenmen (HT7), Hegu (LI4), Zusanli (ST36) and Quchi (LI11)) and connected to the TENS stimulator. These acupoints are selected according to the traditional Chinese medicine and results of previous studies. The stimulation will be lasted 30-min for each session. The frequency of the stimulation parameter'
• Device Sham Acu-TENS
  A dual-channel TENS stimulator will be used (ITO Physiotherapy \& Rehabilitation, Co, Ltd, Tokyo, Japan). Electrodes will be placed over selected acupoints (i.e., bilateral Sanyinjiao (SP6), Neiguan (PC6), Shenmen (HT7), Hegu (LI4), Zusanli (ST36) and Quchi (LI11)) and connected to the TENS stimulator. These acupoints are selected according to the traditional Chinese medicine and results of previous studies. The stimulation will be lasted 30-min for each session. The frequency of the stimulation
• Other SHP
  SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. The sleep guide contains information on how much sleep is needed by every individual daily, factors that could affect sleep, and risk factors for sleep disorders. It also contains information on the types of sleep disorders, delayed sleep syndrome, insomnia-producing behavior that could affect sleep quality, and suggestions for inducing sleep. The participants will be instructed to read the guide after

Primary outcome measures

• Pittsburgh sleep quality index (PSQI) [Time frame: T0, baseline]
• Pittsburgh sleep quality index (PSQI) [Time frame: T1, mid (2th week)]
• Pittsburgh sleep quality index (PSQI) [Time frame: T2, post (4th week)]
• Pittsburgh sleep quality index (PSQI) [Time frame: T3, follow-up(6th week)]
• Total sleep time [Time frame: T0, baseline]
• Total sleep time [Time frame: T2, post (4th week)]
• Total sleep time [Time frame: T3, follow-up(6th week)]
• Sleep efficiency [Time frame: T0, baseline]
• Sleep efficiency [Time frame: T2, post (4th week)]
• Sleep efficiency [Time frame: T3, follow-up(6th week)]

Secondary outcome measures (12)

• Stroop Color and Word Test [Time frame: T0, baseline]
• Stroop Color and Word Test [Time frame: T1, mid (2th week)]
• Stroop Color and Word Test [Time frame: T2, post (4th week)]
• Stroop Color and Word Test [Time frame: T3, follow-up(6th week)]
• Trail making test [Time frame: T0, baseline]
• Trail making test [Time frame: T1, mid (2th week)]
• Trail making test [Time frame: T2, post (4th week)]
• Trail making test [Time frame: T3, follow-up (6th week)]
• 10-m walk test [Time frame: T0, baseline]
• 10-m walk test [Time frame: T1, mid (2th week)]
• 10-m walk test [Time frame: T2, post (4th week)]
• 10-m walk test [Time frame: T3, follow-up (6th week)]

Eligibility criteria

Inclusion criteria

• aged between 55 and 85 yrs;
• diagnosed with stroke by magnetic resonance imaging or computed tomographic scan longer than one year;
• able to walk 6-m independently;
• scored ≥18 but less or equal than 27 in mini-mental state examination (MMSE);
• self-reported poor sleep quality (PSQI, scores ≥ 6) in the past four weeks.

Exclusion criteria

• have a cardiac pacemaker;
• have a severe disease that precludes the receipt of Acu-TENS;
• are taking medication that may affect measured outcomes;
• have skin lesions, infection, or inflammation near selected acupoints;
• are participating in other drug/treatment programs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Hong Kong · 2 centers

• The Hong Kong Polytechnic University — Hong Kong
• The Hongkong Polytechnic University — Hong Kong

Identifiers

NCT: NCT05623137 · 2022ShamayAcu-tens_Stroke

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗