Clinical trial NCT04646577: The Effect of tDCS Combined With Functional Task Training on Motor Recovery in Stroke Patients
Official title: The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Stroke, Acute
Motor Function
Lead sponsor: King Fahad Specialist Hospital Dammam
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: We propose to enhance the effects of brain plasticity using a powerful noninvasive technique for brain modulation consisting of navigated transcranial magnetic stimulation (TMS) priming with transcranial direct current stimulation (tDCS) in combination with motor-training-like constraint-induced movement therapy (CIMT).


Eligibility criteria: Inclusion Criteria:

1. age 18-90
2. first-time clinical ischemic or hemorrhagic cerebrovascular accident as noted in the radiological (or physician's) report;
3. the ability to extend =20° at the wrist and 10° at the metacarpophalangeal and interphalangeal joints of all digits;
4. participants must demonstrate adequate balance while wearing the restraint;
5. the ability to stand from a sitting position and the ability to stand for at least 2 minutes with or without upper extremity support;
6. weakness, defined as score of 15-55 (out of 66) on arm motor Fugl-Meyer (FM) scale; and
7. stroke onset more then 6 months prior to study enrollment.

Exclusion Criteria:

1. significant pre-stroke disability;
2. where applicable (a history of depression before the stroke);
3. any substantial decrease in alertness, language reception, or attention that might interfere with understanding the instructions for the motor testing;
4. excessive pain in any joint of the paretic extremity;
5. contraindications to single-pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants;
6. advanced liver, kidney, cardiac, or pulmonary disease;
7. a terminal medical diagnosis consistent with survival 1 year;
8. coexistent major neurological or psychiatric disease (to decrease the number of confounders);
9. a history of significant drug abuse in the prior 6 months;
10. the use of certain neuropsychotropic drugs such as tricyclics, antidepressants, or 51 of 66 carbamazepine;
11. active enrollment in a separate intervention study targeting stroke recovery; (
12. previously applied constraint-induced motor therapy and/or tDCS treatment for stroke; and
13. a history of epilepsy before stroke (or episodes of seizures within the last six months).

Primary outcomes:
measure: To assess the neurophysiologic findings of cortical plasticity.
timeFrame: Before 10 sessions, before and after each session (every day), after 10 daily sessions and after 6 weeks
measure: To assess the motor function changes .
timeFrame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Secondary outcomes:
measure: Sensory-motor function of the upper limb
timeFrame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
measure: Degree of disability:
timeFrame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Other outcomes:
Locations:
Study officials:
References:
citation: Al-Hussain F, Nasim E, Iqbal M, Altwaijri N, Asim N, Yoo WK, Bashir S. The effect of transcranial direct current stimulation combined with functional task training on motor recovery in stroke patients. Medicine (Baltimore). 2021 Feb 12;100(6):e24718. doi: 10.1097/MD.0000000000024718.