Robotic hand-assisted Transcranial Magnetic Stimulation therapy for rehabilitation from brain damage caused by stroke

Phase 1

Completed

• Conditions: Evaluation of clinical outcomes in response to the robotic hand-assisted Transcranial Magnetic Stimulation (TMS) therapy in patients with stroke; Nervous System Diseases

• Registration Number: ISRCTN95291802
• Lead Sponsor: Science and Engineering Research Board

Brief Summary

2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31545737/ results (added 19/10/2020) 2023 Other publications in https://doi.org/10.3389/fnins.2023.1116273 (added 17/11/2023) 2021 Results article in https://doi.org/10.1186/s12984-021-00867-7 (added 17/11/2023) 2022 Results article in https://doi.org/10.3389/fnins.2022.832121 (added 17/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-03-31
• Study Start: 2020-10-23
• Last Update Posted: 28 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1.18 - 70 years of age
2. Single lesioned, Chronic (3 months - 24 months) stroke
3. Cortical/sub-cortical, Ischemic/Hemorrhagic stroke,
4. Modified Ashworth Scale (1,1+, 2), Brunnstrom stage (3-5), Medical Research Council Scale (2-4),
5. Should have motor cortex MEP >= 10uv in lesion hemisphere,
6. Should have wrist extension EMG activity,
7. Is able to give informed consent
8. Can follow the instruction to execute training task with Mini-Mental Scale (MMS 24 - 30)

Exclusion Criteria

1. Contra-indications to TMS
2. Progressive neurological or cognitive disorders impinging with assessment scales

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
At baseline and 4 weeks:<br>1. Spasticity of wrist joint measured using the Modified Ashworth Scale (MAS)<br>2. Sequence of stages of recovery post-stroke measured using the Brunnstrom stage (BS)<br>3. Functional independence of patient in Activity of Daily Living (ADL) measured using the Barthel Index<br>4. Performance-based sensorimotor function index of whole arm measured using Fugl-Meyer Assessment (FMA)<br>5. Wrist-joint movement without assistance measured through Active Range of Motion on scale: 0 to 70 degrees <br>6. Disability measurement using the Modified Rankin Scale<br>7. Patient experience with the therapy sessions using self-designed subjective questionnaire feedback in terms of use, functionality, ease of use, potential of home-based use, user-friendly etc. <br>8. User-feedback on the usability, complexity and ease of use measured using an industry based System Usability Scale

Secondary Outcome Measures

Name	Time	Method
At baseline and 4 weeks:<br>1. Cortical Excitability measurements: <br>1.1. Peak to peak amplitude (in microvolts) of Motor Evoked Potential (MEP) response of cortex measured using Transcranial Magnetic Stimulation <br>1.2. Resting Motor Threshold Intensity (in %) to generate the MEP measured using Transcranial Magnetic Stimulation <br>1.3. Latency period of MEP (in milliseconds), measured using Transcranial Magnetic Stimulation <br>2. Functional Magnetic Resonance Imaging measures:<br>2.1. Number of active voxels in different regions of brain while performing the wrist extension task, measuring neuronal activity <br>2.2. Volume of activation of brain while performing the wrist extension task, measuring neuronal activity<br>2.3. Structural MRI, measuring any structural changes in brain