Efficacy of the Theta Burst Stimulation and Functional Electrical Stimulation in Stroke Rehabilitation
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Approximately 50% of patients have persistent motor disability following stroke. Current treatment approaches with conventional physiotherapy have limited efficacy. Repetitive transcranial magnetic stimulation (rTMS) and Functional electrical stimulation (FES) have been shown to improve the neuronal plasticity and motor control in few preliminary studies. Their efficacy in human stroke subjects is unproven. We planned to study their efficacy in improving the motor functions of stroke patients in a randomized trial. Sixty consecutive haemodynamically stable adult patients with first ischemic stroke within last 7-30 days were randomized into three treatment groups to receive either physiotherapy alone, or physiotherapy combined with either FES or rTMS. Outcome was assessed using Fugl Meyer assessment for physical performance of upper limb. Three groups were compared for the outcome measures using intention to treat analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2009
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2012
CompletedFirst Submitted
Initial submission to the registry
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedJune 15, 2018
June 1, 2018
2.3 years
June 1, 2018
June 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Fugl Meyer Assessment (FMA) scale
Fugl Meyer Assessment (FMA) scale, is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. We used upper limb motor function domain of FMA scale which is a 66 point domain with a score ranging from 0-66. The lower score indicates more severe disability in upper limb motor functions.
One year
Secondary Outcomes (3)
Modified Rankin Scale
One year
National Institute of Health Stroke Scale (NIHSS)
One year
Barthel Index
One year
Study Arms (3)
Theta burst stimulation & Physiotherapy
EXPERIMENTALPatients were given theta burst stimulation (intermittent TBS (iTBS) to the affected hemisphere and continuous TBS (cTBS) to the unaffected hemisphere) along with physiotherapy. TBS was delivered for 3 times in a week for 4 weeks.The stimulation was given with an intensity of 60% of RMT. The iTBS protocol of 10 bursts of high-frequency stimulation (3 pulses at 50 Hz) was applied at 5 Hz every 10 second for a total of 600 pulses. Continuous TBS (inhibitory) was delivered to the unaffected hemisphere at the "hot-spot" with an intensity of 60% of RMT, 3 pulses at 50 Hz, repeated every 200 ms for a total of 600 pluses.
Functional stimulation & Physiotherapy
EXPERIMENTALPatients in the functional electrical stimulation (FES) group received the electrical stimulation with electrodes positioned according to pattern 3 \[Grasp/Flexion/Extension, PATT (pattern movement)\] of the FES (F) mode of the instrument. The electrodes were connected to a stimulator controller unit that delivers alternating current at a frequency of 35 Hz and a pulse width of 200 µs, intensity 10\~50 mA. The FES group stimulation session was given for 30 minutes for each day 3 times in a week (alternate days) for 4 weeks and it was concurrently synchronized with the physiotherapy.
Physiotherapy
ACTIVE COMPARATORThe following different physiotherapy regimens were followed for all the patients in the study. Passive/Active Range of Motion (ROM); Weight bearing and supportive reaction; Reaching activities; Grasping, holding and release; Upper extremity activities of daily living (ADL). Physiotherapy intervention was given to all the patients 5 days per week for 1 month. In addition, all patients continued to receive in-home physiotherapy 1 to 2 times per week by a home physiotherapist who was guided by the research physiotherapist.
Interventions
Patients were given intermittent TBS to the affected hemisphere and continuous TBS to the unaffected hemisphere for 4 weeks along with physiotherapy.
Patients were given functional electrical stimulation of affected upper extremity for four weeks along with physiotherapy.
Patients received active and passive physiotherapy of the affected extremity for four weeks.
Eligibility Criteria
You may qualify if:
- First episode of ischemic stroke in the internal carotid artery territory defined on CT scan or MRI brain.
- Presentation within 7 days to 1 month of stroke onset.
- Age group between 18-70 years
- Muscle power less than 3 according to Medical Research Council (MRC) Grading
You may not qualify if:
- Brain stem stroke
- Bilateral strokes
- Hemorrhagic stroke
- Significant joint deformity preventing effective physiotherapy
- Severe internal carotid artery stenosis requiring intervention
- Unstable cardiopulmonary status and other diseases which are likely to hamper the 1 year follow up
- Patients with contraindication to transcranial magnetic stimulation
- Patients with previous history of seizures
- Patients on chronic anti-psychiatric and antidepressants drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessor was blinded to the type of intervention.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 1, 2018
First Posted
June 13, 2018
Study Start
October 5, 2009
Primary Completion
January 25, 2012
Study Completion
January 25, 2012
Last Updated
June 15, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- 3 months of request
- Access Criteria
- Data sharing request will be assessed by the investigator.
Annonymized individual participant data will be shared on request. Pl. contact: cbrathore@gmail.com.